Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.
Conditions: Surgical Wound
Sponsor: Cardiva Medical, Inc.

 
CARDIVA Medical, Inc. – ANTEGRADE-PVD REGISTRY 
 
 
 
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“ANTEGRADE-PVD” Post-Market Registry Protocol 
 
A MULTI-CENTER, PROSPECTIVE, POST-MARKET REGISTRY TO EVALUATE PROCEDURAL OUTCOMES 
DATA USING THE CARDIVA VASCADETM VASCULAR CLOSURE SYSTEM (VCS) FOR THE 
MANAGEMENT OF THE FEMORAL ARTERIOTOMY AFTER PERCUTANEOUS ENDOVASCULAR PROCEDURES 
VIA ANTEGRADE ACCESS 
The registry will be performed in accordance with the relevant parts of  
Title 21 CFR Parts 50 and 803 
Sponsor: 
Cardiva Medical, Inc. 
 
Registry 
Responsibility: 
Cardiva Medical, Inc. 
 
Principal 
Investigator: 
Mehdi Shishehbor, DO 
Study Centers: 
Cleveland Clinic Foundation 
Cardiovascular Institute of the South 
San Antonio, Heart, Vascular and Rhythm Center 
North Mississippi Medical Center 
Coastal Surgery Specialists 
Protocol Number: 
PTL 0502-02 
Date of Issue:  
March 7, 2017  / Version 1.0 
 
This protocol contains confidential information for use by the Investigators and 
their designated representatives participating in this clinical registry. It should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission. 
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Investigator’s Agreement / Signature Page 
 
STUDY TITLE: 
ANTEGRADE-PVD Post-Market Registry Protocol 
A MULTI-CENTER, PROSPECTIVE, POST-MARKET REGISTRY TO EVALUATE 
PROCEDURAL OUTCOMES DATA USING THE CARDIVA VASCADETM 
VASCULAR CLOSURE SYSTEM (VCS) FOR THE MANAGEMENT OF THE FEMORAL 
ARTERIOTOMY AFTER PERCUTANEOUS ENDOVASCULAR PROCEDURES VIA 
ANTEGRADE ACCESS 
 
PROTOCOL 
NUMBER: 
PTL 0502-02 
VERSION 
NUMBER: 
1.0 
DATE: 
March 7, 2017 
 
STUDY CENTER: 
 
_____________________________________________ 
 (Print site name and number) 
 
I, the undersigned, have read and understand the protocol specified above 
and agree on its content. I agree to perform and conduct the registry as 
described in the protocol.  
 
 
______________________________________________________________________ 
Print Investigator Name           
 Principal Investigator  
 Co-Investigator 
 
 
______________________________________________________________________   
Signature                                                                               Date 
 
 
 
 
 
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Protocol Synopsis 
ANTEGRADE-PVD Post-Market Registry Protocol 
A MULTI-CENTER, PROSPECTIVE, POST-MARKET REGISTRY TO EVALUATE PROCEDURAL OUTCOMES 
DATA USING THE CARDIVA VASCADETM VASCULAR CLOSURE SYSTEM (VCS) FOR THE 
MANAGEMENT OF THE FEMORAL ARTERIOTOMY AFTER PERCUTANEOUS ENDOVASCULAR PROCEDURES 
VIA ANTEGRADE ACCESS 
Primary 
Objective 
The objective of the ANTEGRADE-PVD registry is to collect procedural 
outcomes data when the Cardiva VASCADETM Vascular Closure 
System (VCS) is used to seal femoral arterial access sites at the 
completion of ipsilateral peripheral interventional procedures 
performed through 5-7 Fr introducer sheaths via an antegrade 
approach.  
Antegrade access is experiencing growing adoption in catheter-
based procedures to treat peripheral artery disease, with many 
advantages for lower limb procedures in particular. This post-market 
registry is designed to capture data specific to this procedural 
technique, and is being conducted under an FDA-approved 
indication for use for this device. 
Device 
The Cardiva VASCADETM Vascular Closure System (VCS) is an FDA-
approved device (PMA P120016). 
Approved 
Indication 
for Use 
The Cardiva VASCADETM Vascular Closure System (VCS) is indicated 
for femoral arterial access site closure while reducing times to 
hemostasis and ambulation in patients who have undergone 
diagnostic or interventional endovascular catheterization 
procedures utilizing a 5 Fr, 6 Fr or 7 Fr procedural sheath.  
Study Design 
A multi-center, prospective, single arm post-market registry  
Number of 
Subjects 
Up to 100 prospectively enrolled subjects  
Number of Sites 
Investigators experienced in antegrade access closure w/VASCADE 
VCS will enroll subjects at up to 7 U.S. sites 
Study Duration 
It is anticipated that enrollment will commence in December 2016, 
with final enrollment and 30 day follow-ups completed in Q3 2017. 
The registry will be considered complete after all enrolled subjects 
have completed the registry follow-up requirements. 
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Follow-up 
Schedule 
Each enrolled subject will be followed for up to 30 +/-7 days post-
procedure. There will be an office visit between 1-15 days; and a 
subsequent telephone follow-up will be done between 23-37 days as 
the final contact.  
Primary 
Procedural 
Outcome – 
Performance 
 
Time to hemostasis (TTH), defined as elapsed time between 
device removal and first observed and confirmed arterial 
hemostasis. 
Secondary 
Procedural 
Outcomes - 
Performance 
 
 
Time to ambulation (TTA), defined as elapsed time between 
device removal and when subject first stands and walks 20 feet 
without evidence of arterial re-bleeding from the access site. 
 
Time to hospital discharge (TTD), defined as elapsed time 
between device removal and when subject is actually 
discharged from the facility. 
 
Device Success, defined as the ability to deploy the delivery 
system, deliver the collagen, and achieve hemostasis with the 
Cardiva VASCADETM VCS alone or with adjunctive compression  
 
Procedure Success, defined as attainment of Device Success 
and freedom from major access site closure-related 
complications through 30 days 
Primary 
Procedural 
Outcomes - 
Complications  
Patient incidence rate of combined major access site closure-
related complications through 30 days: 
 Access site closure-related bleeding requiring transfusion; 
 Vascular injury requiring repair (via surgery, ultrasound guided 
compression, transcatheter embolization or stent graft); 
 New ipsilateral lower extremity ischemia causing a threat to the 
viability of the limb and requiring surgical or additional 
percutaneous intervention; 
 Access site-related infection requiring intravenous antibiotics 
and/or extended hospitalization; 
 New onset neuropathy in the ipsilateral lower extremity requiring 
surgical repair 
 New onset permanent nerve injury in the ipsilateral lower 
extremity (> 30 days) 
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Secondary 
Procedural 
Outcomes - 
Complications 
Patient incidence rate of combined minor access site closure-
related complications through 30 days: 
 Access site-related bleeding requiring greater than 30 minutes to 
achieve initial arterial hemostasis; 
 Access site-related hematoma > 6 cm documented by 
ultrasound; 
 Late access site-related arterial bleeding requiring intervention 
(following hospital discharge); 
 Ipsilateral lower extremity arterial emboli documented by 
ultrasound/imaging; 
 Ipsilateral deep vein thrombosis documented by ultrasound; 
 Access site-related vessel laceration; 
 Access site wound dehiscence; 
 Localized access site infection treated with intramuscular or oral 
antibiotics; 
 Arteriovenous fistula not requiring treatment, documented by 
ultrasound/imaging; 
 Pseudoaneurysm requiring thrombin injection or fibrin adhesive 
injection; 
 New onset neuropathy in the ipsilateral lower extremity not 
requiring surgical repair. 
Pre-Operative 
Inclusion Criteria 
1. 18 to 80 years of age; 
2. Capable and willing to give informed consent; 
3. Acceptable candidate for an elective, non-emergent ipsilateral 
peripheral interventional endovascular procedure via antegrade 
access of the femoral artery using a 5, 6 or 7 Fr introducer sheath;  
4. Acceptable candidate for post-procedural manual compression; 
5. Able and willing to complete a follow-up office visit between 1-15 
days post-procedure, and subsequent follow-up telephone 
assessment between 23-37 days; 
6. Subject is able to ambulate at least 20 feet, with or without 
assistance (e.g., ambulatory amputee); 
7. Acceptable candidate for emergent vascular surgery. 
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Pre-Operative 
Exclusion Criteria 
Subjects will be excluded from participating in this registry if they 
meet any of the following criteria prior to initiation of the 
endovascular procedure: 
1.  Advanced refusal of blood transfusion, if necessary; 
2. Active systemic or cutaneous infection or inflammation; 
3. Pre-existing immunodeficiency disorder and/or chronic use of 
systemic steroids; 
4. Known, significant history of bleeding diathesis, coagulopathy, or 
current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or 
fibrinogen level less than 150 mg/dl (if received a fibrinolytic 
agent within prior 24 hours) based on institution’s standard pre-
operative lab values; 
5. Severe co-existing morbidities having a life expectancy of less 
than 90 days; 
6. Currently involved in any investigational clinical trials that have 
not completed their primary endpoint and/or may interfere with 
the conduct of this registry, per Investigator’s assessment;  
7. Previous ipsilateral femoral arteriotomy with any of the following 
conditions: 
a. access within < 10 days 
b. any residual hematoma, significant bruising, or known 
associated vascular complications; 
c. within < 90 days, use of an intra-vascular closure device (i.e., 
Angioseal); 
8. Planned / staged endovascular or surgical procedures within the 
next 10 days, prior to office visit (excluding planned/anticipated 
minor amputation);  
9. Previous vascular grafts or surgery at the target vessel access site; 
10. Known history of deep vein thrombosis in the ipsilateral limb 
within the past 30 days, unless confirmed to be resolved by 
ultrasound prior to enrollment; 
11. Major amputation (i.e., above the ankle) of the ipsilateral lower 
extremity is planned/anticipated within next 30 (+ 7) days, prior to 
study exit:  
12. Large pannus, which may prevent antegrade access without 
significant tissue displacement, in the opinion of the investigator; 
13. Significant anemia with a hemoglobin level less than 10 g/dL or 
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a hematocrit less than 30% based on institution’s standard pre-
operative lab values; 
14. Renal insufficiency (serum creatinine of > 2.5 mg/dl); 
15. Females who are pregnant, planning to become pregnant 
within 3 months of the procedure, or lactating; 
16. Extreme morbid obesity (BMI greater than 45 kg/m2) or 
underweight (BMI less than 20 kg/m2); 
17. Known allergy/adverse reaction to bovine derivatives; 
18. Administration of low molecular weight heparin (LMWH) within 8 
hours of the procedure. 
 
Intra-Operative 
Exclusion Criteria 
Subjects will be excluded from participating in this registry if any of 
the following exclusion criteria occur during the endovascular 
procedure, prior to enrollment (i.e., prior to insertion of VASCADE 
VCS): 
1. Use of a final introducer sheath > 12 cm (or > 15 cm in overall 
length), or not 5, 6 or 7 Fr diameter; 
2. Contralateral femoral arterial access with > 5 Fr catheter that is 
not successfully closed with a closure device during the index 
procedure; 
3. Index groin involves a previously placed permanent closure 
device (e.g., Starclose), where the device cannot be visualized 
to confirm that it is at least 1 cm proximal or distal to the puncture 
site; 
4. Femoral artery diameter less than 6 mm at access site; 
5. Angiographic evidence of moderate to severe calcium, > 50% 
stenosis, or a stent within 1 cm of the puncture site; 
6. Overlapping Common Femoral Vein and Femoral Artery at 
access site; 
7. Presence or placement of ipsilateral venous sheath during 
procedure; 
8. Antegrade arterial access site: 
 a. is a side stick 
 b. is NOT a single anterior wall femoral puncture  
 c. is NOT below the inguinal ligament / lower half of femoral 
head and not below the inferior epigastric artery origin from the 
external iliac artery;  
9. More than one ipsilateral arterial access site is required in the 
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index limb (e.g., femoral or other); 
10. Intra-procedural bleeding around sheath, or suspected 
intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula; 
11. Evidence of arterial insufficiency, emboli, or new stenosis / 
occlusion in the ipsilateral limb at the conclusion of the index 
intervention (i.e., complications occurring from untreated, or 
suboptimal treatment of disease); 
12. Systemic hypertension (BP greater than 180/110 mmHg) or 
hypotension (BP less than 90/60 mmHg) just prior to enrollment; 
13. Length of the tissue tract, the distance between the anterior 
arterial wall and skin, is estimated to be less than 2.5 cm; 
14. If the physician deems that a different method should be used 
to achieve hemostasis of the arterial site; 
15. Upon final angio/fluoro assessment of the final introducer sheath 
to be used for VASCADE delivery, documented evidence of:  
a. inadequate sheath placement (e.g., location, position, angle), 
and/or  
b. any kinking of the procedural sheath prior to enrollment and 
insertion of the VASCADE VCS. 
Study Administration 
Sponsor 
Cardiva Medical, Inc. 
2900 Lakeside Drive, Suite 160 
Santa Clara, CA 95054 
Clinical CRO & 
Data 
Management 
Chellew Clinical Outsourcing, LLC 
7844 E. Riverdale St.  
Mesa, AZ 85207 
Safety 
Monitoring 
An Independent Physician Adjudicator (IPA) will review and 
adjudicate all serious device-related adverse event reports, deaths, 
and all minor and major access site closure-related complications for 
a determination of both seriousness and closure-relatedness.  
All adverse events and device failures will be evaluated as 
complaints and determinations made as to whether the complaint 
represents an event which is required to be reported to FDA under 21 
CFR Part 803, Medical Device Reporting. 
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Table of Contents 
Protocol Approval Page.......................................................................................................... 2 
Investigator’s Agreement / Signature Page ......................................................................... 3 
Protocol Synopsis ...................................................................................................................... 4 
Table of Contents ................................................................................................................... 10 
1. Introduction ...................................................................................................................... 13 
1.1. Background and Rationale .................................................................................... 13 
1.2. Risks and Benefits ...................................................................................................... 14 
1.2.1. Risks ....................................................................................................................... 14 
1.2.2. Potential Benefits ................................................................................................ 14 
2. Device Description .......................................................................................................... 15 
2.1. Device Labeling ........................................................................................................ 15 
2.2. Previous Clinical Experience ................................................................................... 15 
3. Study Objective ............................................................................................................... 16 
4. Study Design ..................................................................................................................... 16 
4.1. Overview .................................................................................................................... 16 
4.2. Sample Size ................................................................................................................ 16 
4.3. Investigational Sites .................................................................................................. 16 
5. Subject Population .......................................................................................................... 17 
5.1. Selection Criteria ...................................................................................................... 17 
5.1.1. Pre- Operative Inclusion Criteria ...................................................................... 17 
5.1.2. Pre-Operative Exclusion Criteria ....................................................................... 17 
5.1.3. Intra-Operative Exclusion Criteria .................................................................... 19 
5.2. Withdrawal of Subjects ............................................................................................ 20 
6. Written Informed Consent – 21 CFR 50 Protection of Human Subjects ................... 20 
7. Study Procedures and Enrollment ................................................................................. 21 
7.1. Duration of Subject Participation ........................................................................... 21 
7.2. Enrollment .................................................................................................................. 21 
7.3. Event Schedule ......................................................................................................... 22 
7.4. Study Procedures ...................................................................................................... 23 
7.4.1. Pre-Operative (up to 8 weeks before procedure) ........................................ 23 
7.4.2. Intra-Operative ................................................................................................... 23 
7.4.3. Access Site Closure ............................................................................................ 24 
7.4.4. Post-Operative .................................................................................................... 25 
7.5. Follow-up .................................................................................................................... 25 
7.6. Study Exit .................................................................................................................... 26 
8. Assessment of Procedural Outcomes .......................................................................... 26 
8.1. Primary Procedural Outcomes - Performance ..................................................... 26 
8.2. Secondary Procedural Outcomes - Performance .............................................. 26 
8.3. Primary Procedural Outcomes - Complications .................................................. 27 
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8.4. Secondary Procedural Outcomes - Complications ............................................ 27 
9. Statistical Considerations ............................................................................................... 28 
9.1. Analysis Populations and Data Handling Conventions....................................... 28 
9.1.1. Intent to Treat (ITT) Population .......................................................................... 28 
9.1.2. Per Protocol (PP) Population ............................................................................. 28 
9.1.3. Missing Data ........................................................................................................ 28 
9.2. Statistical Analysis Plan ............................................................................................. 28 
9.2.1. General Analysis Principles ................................................................................ 28 
9.2.2. Performance Outcomes .................................................................................... 29 
9.2.3. Complication Outcomes .................................................................................. 29 
9.3. Sample Size Estimation ............................................................................................. 30 
10. Data Management – Data Collection and Processing ............................................ 30 
11. Monitoring Procedures ................................................................................................... 30 
11.1. Monitoring ................................................................................................................. 30 
11.2. Commercial Device Distribution and Accountability......................................... 31 
11.2.1. Commercial Device Distribution ...................................................................... 31 
11.2.2. Device Accountability ....................................................................................... 31 
12. Quality Control and Quality Assurance ....................................................................... 31 
12.1. Site Training ............................................................................................................... 31 
12.2. Physician Training ..................................................................................................... 31 
13. Adverse Events and Device Failure Reporting Requirements .................................. 32 
13.1. Regulatory Requirements – 21 CFR 803 Medical Device Reporting for 
Commercially Available Devices .......................................................................... 32 
13.2. Reporting Guidelines ............................................................................................... 33 
13.2.1. Serious Adverse Events or Injuries ..................................................................... 33 
13.2.2. Device Failures or Malfunction ......................................................................... 33 
13.3. Registry Reporting Requirements for Adverse Events ......................................... 33 
14    Ethical Considerations ................................................................................................... 34 
14.1   Institutional Review Board Approval ..................................................................... 34 
14.2 Informed Consent Form – 21 CFR 50 Protection of Human Subjects ................ 35 
14.3   Protocol Deviations .................................................................................................. 35 
14.4   Coverage of Expenses ............................................................................................ 36 
14.5 Confidentiality .......................................................................................................... 36 
15 Administration .................................................................................................................. 36 
15.1   Pre-Enrollment Documentation Requirements .................................................... 36 
15.2 Source Documentation ........................................................................................... 36 
15.3 Criteria for Terminating Study ................................................................................. 37 
15.4 Criteria for Suspending/Terminating a Study Center .......................................... 37 
15.5 Investigator Responsibilities .................................................................................... 37 
16 Publication Policy ............................................................................................................ 38 
17 Responsibilities ................................................................................................................. 38 
17.1 Role of Cardiva Medical ......................................................................................... 38 
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17.2 Monitoring ................................................................................................................. 38 
17.3 Maintaining Records ................................................................................................ 38 
18 Abbreviations and Definitions ....................................................................................... 38 
18.1 Abbreviations ............................................................................................................ 38 
18.2 Definitions .................................................................................................................. 39 
18.3 Bibliography .............................................................................................................. 47 
19 Attachment 1: Sample Informed Consent Form ........................................................ 49 
20 Attachment 2: Instructions For Use (IFU) ....................................................................... 50 
 
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1. Introduction  
1.1. Background and Rationale 
The Cardiva VASCADE Vascular Closure System (VCS) is designed to deliver a 
resorbable collagen patch, extravascularly at the arteriotomy site to aid in achieving 
hemostasis. The collagen patch is designed to seal the arteriotomy within minutes and 
be resorbed in approximately three months. There are two versions of the product; 
one is for use in 5 Fr 12 cm introducer sheaths and the other for use in in 6 or 7 Fr 12 cm 
introducer sheaths.  
The safety and effectiveness of this device has been shown in several studies of 
retrograde access closure with very low complication rates and improved times to 
hemostasis and ambulation, compared to manual compression subjects (1). Results of 
the RESPECT Trial led to FDA’s PMA approval of the Cardiva VASCADETM VCS on Jan. 
31, 2013, and it is currently commercially available in the U.S., and in Europe under the 
CE-mark.  
The use of alternate approaches to arterial access for percutaneous transfemoral 
revascularization has been on the rise in the U.S. and abroad, as advances in 
technology have broadened treatment options for patients needing treatment in the 
lower extremity vasculature. Antegrade punctures of the femoral artery often require 
a steeper puncture angle and can be technically more challenging, especially in 
obese patients. However, antegrade femoral puncture is commonly performed in 
patients with infrainguinal vascular disease, and allows the operator to treat ipsilateral 
lower limb lesions with better manipulation, support and pushability of wires and 
catheters, when compared to femoral retrograde, cross-over access (2-5). Manual 
compression is still regarded as the gold standard for achieving hemostasis and is 
widely used in both antegrade and retrograde access, but it has long been 
associated with patient discomfort associated with groin pressure and prolonged 
immobilization (5).  
Although most vascular closure devices have been routinely tested for safety and 
efficacy in retrograde access procedures, these same devices are being successfully 
used in antegrade access diagnostic and interventional peripheral procedures (6).   
There have been many single-center and multi-center studies conducted to examine 
procedural outcomes when VCDs are used to close antegrade femoral access sites. 
Although the vast majority of these studies are limited to retrospective analyses, the 
major complication rates have been reportedly similar to those reported in 
retrograde evaluations with these commercial devices (4-10). However, due to major 
inconsistencies in study methods, definitions and reporting among currently published 
studies, it is difficult to make a meaningful comparison of outcomes across studies 
and devices (7). 
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Due to the growing adoption of antegrade femoral access and the use of VCDs to 
close these arteriotomies, it is important to collect performance and complication 
outcomes data related to this procedural variable. The aim of the ANTEGRADE-PVD 
registry is to consistently collect prospective data on procedural outcomes in 
antegrade access cases closed with the VASCADE VCS in a way that is consistent 
with the RESPECT Study design and the FDA-approved Instructions for Use (IFU). 
1.2. Risks and Benefits 
1.2.1. Risks 
Risks associated with the VASCADE VCS are similar to those associated 
with other extravascular methods of achieving hemostasis at arteriotomy 
sites.  Complications that may occur include:  
 
Allergic response  
 
Arterial occlusion 
 
Arterial thrombus  
 
Arterio-venous fistula  
 
Bleeding/oozing from the puncture site 
 
Bruising at wound site 
 
Death 
 
Device failure / malfunction 
 
Edema 
 
Embolization tissue (thrombus, air, calcific debris, device)  
 
Hematoma 
 
Infection 
 
Inflammatory response 
 
Intimal tear / dissection 
 
Laceration of the vessel wall 
 
Lower extremity ischemia 
 
Peripheral nerve injury 
 
Perforation of the vessel wall 
 
Pseudoaneurysm 
 
Retroperitoneal bleeding  
 
Thrombus formation 
 
Vasovagal response 
 
Vasospasm 
 
Vascular injury 
 
Wound dehiscence 
 
Wound site pain 
Previous evaluations have not shown any additional risks in comparison to 
those associated with other compression-based hemostasis methods. 
1.2.2. Potential Benefits 
In the RESPECT IDE Trial, demonstrated benefits of the VASCADETM 
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Vascular Closure System over manual compression alone to achieve 
hemostasis included reduced time to hemostasis and time to ambulation 
in both diagnostic and interventional subjects.   
This registry is intended to evaluate the potential benefit of reduced time 
to hemostasis, time to ambulation and time to discharge in interventional 
subjects undergoing antegrade access, while also evaluating procedural 
complications. Although antegrade access is a procedural technique 
that is gaining favor among clinicians for the treatment of ipsilateral 
peripheral disease, prospective enrollment and evaluation of outcomes 
related to vessel closure is lacking. Data collected in this registry may 
benefit clinicians in decision-making related to these types of procedures.  
2. Device Description 
The Cardiva VASCADE Vascular Closure System (VCS) is designed to deliver a 
resorbable Collagen Patch, extravascularly at the arteriotomy site to aid in achieving 
hemostasis. The collagen patch is designed to seal the arteriotomy within minutes and 
be resorbed in approximately three months. There are two versions of the product; 
one is for use in 5 Fr 12 cm introducer sheaths and the other for use in in 6 or 7 Fr 12 cm 
introducer sheaths.  
Refer to Attachment 2: Instructions for Use for a complete description of the device, 
warnings and precautions, and a summary of the PMA (P120016) Summary of Safety 
and Effectiveness Data.  
2.1. Device Labeling 
A copy of the Instructions for Use (IFU) will be included with the devices.  The 
Cardiva VASCADETM Vascular Closure Systems (VCS) are commercially labeled 
for sale in the United States and contain the following information:  
 
Product Name 
 
Part number 
 
Lot number 
 
Expiration (use before) date 
 
2.2. Previous Clinical Experience 
VASCADE 6/7 Fr VCS was evaluated in a prospective, multi-center, randomized 
(2:1) clinical trial (the RESPECT Trial) in 20 sites in the United States and one site in 
Australia, comparing VASCADE VCS to Manual Compression (MC). The trial 
involved 420 patients undergoing diagnostic (n=211) or interventional (n=209) 
endovascular procedures.  
VASCADE 5 Fr was evaluated in a prospective, single treatment, single-center 
study to confirm the safety and effectiveness of the scaled-down 5 Fr version of 
the VASCADE 6/7 Fr VCS. 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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Conclusions: The results from the RESPECT clinical trial demonstrated that patients 
who have undergone diagnostic or interventional cardiac or peripheral vascular 
endovascular procedures using a 6 or 7 Fr introducer sheath and were treated 
with VASCADE VCS have statistically and clinically significant decreased times to 
hemostasis and ambulation for diagnostic and interventional procedures, when 
compared to patients treated with manual compression. In addition, the trial 
demonstrated that patients treated with the VASCADE VCS were non-inferior to 
patients treated with manual compression with respect to major access site-
related complications, with 0 (0%) major access site-related complications 
reported in both VASCADE and control cohorts. A confirmatory clinical study 
and engineering analysis demonstrated that the VASCADE 5 Fr VCS is equivalent 
to the VASCADE 6/7 Fr VCS in design and performance (1). Refer to Attachment 
2: Instructions for Use for detailed study information. 
3. Study Objective 
The objective of the ANTEGRADE-PVD registry is to collect procedural outcomes 
data when the Cardiva VASCADETM Vascular Closure System (VCS) is used to 
seal femoral arterial access sites at the completion of ipsilateral peripheral 
interventional procedures performed through 5-7 Fr introducer sheaths via an 
antegrade approach. Antegrade access is experiencing growing adoption in 
catheter-based procedures to treat peripheral artery disease, with many 
advantages for lower limb procedures in particular. This post-market registry is 
being conducted under an FDA-approved indication for use for this device. 
4. Study Design 
4.1. Overview 
The ANTEGRADE-PVD registry is a multi-center, single arm post-market registry to 
evaluate procedural outcomes in subjects when the Cardiva VASCADETM 
Vascular Closure System (VCS) is used to seal femoral arterial access sites at the 
completion of ipsilateral peripheral interventional procedures performed 
through 5-7 F introducer sheaths via an antegrade approach.  
Procedural outcomes related to performance and complications will be 
assessed through hospital discharge and 30 (+/- 7) days post-procedure. 
4.2. Sample Size 
Up to 100 subjects will be prospectively enrolled in this registry.   
4.3. Investigational Sites 
This registry will be conducted at up to 7 clinical sites in the United States. 
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5. Subject Population 
5.1. Selection Criteria 
The following pages outline the specific inclusion and exclusion criteria for the 
registry. Before enrollment in the registry, a patient must meet all of the inclusion 
and exclusion criteria requirements. 
5.1.1. Pre- Operative Inclusion Criteria 
All subjects are required to meet the following inclusion criteria in order to 
be considered eligible for participation in this registry: 
 
Pre-Operative 
Inclusion Criteria 
1. 18 to 80 years of age; 
2. Capable and willing to give informed consent; 
3. Acceptable candidate for an elective, non-emergent 
ipsilateral peripheral interventional endovascular procedure 
via antegrade access of the femoral artery using a 5, 6 or 7 Fr 
introducer sheath;  
4. Acceptable candidate for post-procedural manual 
compression; 
5. Able and willing to complete a follow-up office visit between 1-
15 days post-procedure, and subsequent follow-up telephone 
assessment between 23-37 days; 
6. Subject is able to ambulate at least 20 feet, with or without 
assistance (e.g., ambulatory amputee); 
7. Acceptable candidate for emergent vascular surgery. 
 
5.1.2. Pre-Operative Exclusion Criteria 
Subjects will be excluded from participating in this registry if they meet 
any of the following exclusion criteria prior to initiation of the 
endovascular procedure: 
 
Pre-Operative 
Exclusion Criteria 
1.  Advanced refusal of blood transfusion, if necessary; 
2. Active systemic or cutaneous infection or inflammation; 
3. Pre-existing immunodeficiency disorder and/or chronic use of 
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systemic steroids; 
4. Known, significant history of bleeding diathesis, coagulopathy, or 
current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or 
fibrinogen level less than 150 mg/dl (if received a fibrinolytic 
agent within prior 24 hours) based on institution’s standard pre-
operative lab values; 
5. Severe co-existing morbidities having a life expectancy of less 
than 90 days; 
6. Currently involved in any investigational clinical trials that have 
not completed their primary endpoint and/or may interfere with 
the conduct of this registry, per Investigator’s assessment;  
7. Previous ipsilateral femoral arteriotomy with any of the following 
conditions: 
a. access within < 10 days 
b. any residual hematoma, significant bruising, or known 
associated vascular complications; 
c. within < 90 days, use of an intra-vascular closure device (i.e., 
Angioseal); 
8. Planned / staged endovascular or surgical procedures within the 
next 10 days, prior to office visit (excluding planned/anticipated 
minor amputation);  
9. Previous vascular grafts or surgery at the target vessel access site; 
10. Known history of deep vein thrombosis in the ipsilateral limb 
within the past 30 days, unless confirmed to be resolved by 
ultrasound prior to enrollment; 
11. Major amputation (i.e., above the ankle) of the ipsilateral lower 
extremity is planned/anticipated within the next 30 (+/- 7) days, 
prior to study exit; 
12. Large pannus, which may prevent antegrade access without 
significant tissue displacement, in the opinion of the investigator; 
13. Significant anemia with a hemoglobin level less than 10 g/dL or 
a hematocrit less than 30% based on institution’s standard pre-
operative lab values; 
14. Renal insufficiency (serum creatinine of > 2.5 mg/dl); 
15. Females who are pregnant, planning to become pregnant 
within 3 months of the procedure, or lactating; 
16. Extreme morbid obesity (BMI greater than 45 kg/m2) or 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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underweight (BMI less than 20 kg/m2); 
17. Known allergy/adverse reaction to bovine derivatives; 
18. Administration of low molecular weight heparin (LMWH) within 8 
hours of the procedure. 
 
 
5.1.3.  Intra-Operative Exclusion Criteria 
Subjects will be excluded from participating in this registry if any of the following 
exclusion criteria occur during the intravascular procedure, prior to enrollment 
(i.e., prior to insertion of VASCADE VCS): 
 
Intra-Operative 
Exclusion Criteria 
1.  Use of a final introducer sheath > 12 cm (or > 15 cm in overall 
length), or not 5, 6 or 7 Fr diameter; 
2. Contralateral femoral arterial access with > 5 Fr catheter that 
is not successfully closed with a closure device during the 
index procedure  
3. Index groin involves a previously placed permanent closure 
device (e.g., Starclose), where the device cannot be 
visualized to confirm that it is at least 1 cm proximal or distal to 
the puncture site; 
4. Femoral artery diameter less than 6 mm at access site; 
5. Angiographic evidence of moderate to severe calcium, > 50% 
stenosis, or a stent within 1 cm of the puncture site; 
6. Overlapping Common Femoral Vein and Femoral Artery at 
access site; 
7. Presence or placement of ipsilateral venous sheath during 
procedure; 
8. Antegrade arterial access site: 
 a. is a side stick 
 b. is NOT a single anterior wall femoral puncture  
 c. is NOT below the inguinal ligament / lower half of femoral 
head and NOT below the inferior epigastric artery origin from 
the external iliac artery; 
9. More than one ipsilateral arterial access site is required in the 
index limb (e.g., femoral or other); 
10. Intra-procedural bleeding around sheath, or suspected 
intraluminal thrombus, hematoma, pseudoaneurysm, or AV 
fistula; 
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11. Evidence of arterial insufficiency, emboli, or new stenosis / 
occlusion in the ipsilateral limb at the conclusion of the index 
intervention (i.e., complications occurring from untreated, or 
suboptimal treatment of disease); 
12. Systemic hypertension (BP greater than 180/110 mmHg) or 
hypotension (BP less than 90/60 mmHg) just prior to enrollment; 
13. Length of the tissue tract, the distance between the anterior 
arterial wall and skin, is estimated to be less than 2.5 cm; 
14. If the physician deems that a different method should be 
used to achieve hemostasis of the arterial site; 
15. Upon final angio/fluoro assessment of the final introducer 
sheath to be used for VASCADE delivery, documented 
evidence of:  
a. inadequate sheath placement (e.g., location, position, 
angle), and/or  
     b. any kinking of the procedural sheath prior to enrollment 
and  
         insertion of the VASCADE VCS. 
 
5.2. Withdrawal of Subjects 
While withdrawal is discouraged, subjects may withdraw from the registry at any 
time, with or without reason and without prejudice to further treatment. In all 
cases of withdrawal, the reason(s) for withdrawal (if given) will be recorded upon 
registry termination. 
In addition, the Investigator may withdraw the subject due to any reason 
determined by the Investigator to be in the best interest of the subject. 
Subjects withdrawn from the registry prior to hemostasis (e.g., after enrollment 
and prior to deployment of the collagen plug) should be converted to 
conventional means (manual compression) to achieve hemostasis.  
6. Written Informed Consent – 21 CFR 50 Protection of Human Subjects 
Patients who meet general entry criteria will be asked to sign the registry-specific, 
Institutional Review Board (IRB) -approved Informed Consent form before any 
registry-specific data are collected. The informed consent will be reviewed and 
approved by Cardiva Medical prior to IRB submission to ensure compliance with all 
applicable requirements of 21 CFR 50. 
Since this is a post-market registry, subjects will be treated and followed according 
to the institution’s accepted standard of care and in adherence with the protocol. 
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There are no additional tests. Standard of care for office visit follow-up timing for 
these subjects varies between sites and procedure-types, therefore a wide window 
for the office visit has been established to accommodate as many subjects as 
possible.  The required office visit may be performed between 1-15 days post-
procedure, followed by a telephone follow-up between 23-37 days for final 
assessment of any complications. These contacts are required so that Procedure 
Success can be evaluated at 30 days, and to ensure that outcomes are consistently 
reported according to industry standards.  
Study personnel should explain that even if a patient agrees to participate in the 
registry and signs an informed consent form, the Investigator may still determine that 
the patient is not a suitable candidate for the registry.  
A Screening/Enrollment Log will be maintained to document select information 
about candidates who are consented, but who are not enrolled due to failure to 
meet the entry criteria.  
7. Study Procedures and Enrollment 
7.1. Duration of Subject Participation 
Subjects enrolled in the registry will participate for approximately 30 (+/- 7) days. 
7.2. Enrollment 
At the completion of the endovascular procedure, patients who meet all the 
pre- and intra-operative eligibility criteria may be enrolled in the registry and are 
eligible to receive the VASCADE VCS for access site hemostasis as part of the 
registry.  The Investigator will acknowledge intention to enroll the patient prior to 
VASCADE VCS insertion into the procedural sheath, and it will be documented 
on a source worksheet. Once Investigator acknowledgement has been made 
and the device has entered the body, the subject is considered enrolled into the 
registry and should complete all evaluations and follow-up requirements.  An 
Enrollment Notification eCRF must be completed and submitted within 24 hours 
to notify Sponsor of enrollment. 
If a patient does not meet all eligibility criteria for the registry, the patient may 
receive one of the following to achieve arterial hemostasis, at the Investigator’s 
discretion: 1) the VASCADE VCS as a commercial device, but the subject will not 
be enrolled in the registry; 2) another commercially available closure device; or 
3) manual compression. These patients and the final reason for registry exclusion 
will be documented on the Screening/Enrollment Log. 
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7.3. Event Schedule 
Table 1 outlines the required registry assessments. 
Table 1.   Registry Event Schedule 
 
Up to 8 
Weeks 
Before 
Procedure 
 
Procedure 
Post-
Procedure/ 
Hospital 
Discharge 
1-15 Days 
Post-
Procedure 
23-37 Days 
Post-
Procedure 
Informed Consent1 
X 
 
 
 
 
Demographics/ Medical 
History / Risk Factors 
X 
 
 
 
 
Index limb assessment2 
X 
 
X 
X 
X 
Femoral access site 
assessment (angiographic) 
 
X 
X 
X 
X 
Anticoagulant/antiplatelet 
regimen3 
X 
X 
X 
 
 
Pre-op Inclusion / Exclusion 
Criteria assessment 
X 
 
 
 
 
Laboratory tests4 
X 
 
 
 
 
Intra-procedural Exclusion 
Criteria assessment & 
acknowledgement of intent 
to enroll 
 
X 
 
 
 
Treated with VASCADE VCS 
 
X 
 
 
 
TTH determination 
 
X 
 
 
 
TTA determination 
 
 
X 
 
 
TTD determination 
 
 
X 
 
 
Procedure Success 
 
X 
 
 
X 
Adverse Events5 
 
X 
X 
X 
X 
Office Visit 
 
 
 
X 
 
Telephone follow-up 
 
 
 
 
X 
1 If informed consent is obtained > 30 days prior to procedure, the subject’s verbal re-
confirmation of consent should be documented in the medical record prior to the 
procedure. 
2 Index limb assessment includes Rutherford Classification, assessment of peripheral 
pulses, any wounds, amputation history and/or planned amputation, existing 
neuropathy, and ambulatory status.  
3 Specific medication regimen within 24 hours prior to enrollment through completion of 
index procedure.  
4 For subjects on warfarin, INR should be taken within 24 hours before procedure. 
“Laboratory tests” refer to exclusion criteria requirements, according to standard of care 
for these procedures at each site. 
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5 Required adverse event reports: serious, device-related injury or death; minor or major 
access site closure-related complications; any event that is deemed by Investigator to 
be clinically significant AND related to the device, the access site or the index limb (See 
Section 13). 
7.4. Study Procedures 
7.4.1. Pre-Operative (up to 8 weeks before procedure) 
After informed consent and prior to the subject’s scheduled procedure, obtain: 
 Medical history and risk factors  
 Surgical and interventional procedural history 
 Demographics (age, race, gender, ht, wt) 
 Index limb assessment (Rutherford Classification, pulses, wounds, previous 
amputation, existing neuropathy, ambulatory status) 
 Screening laboratory draws (according to institution’s standard of care): 
 
Serum creatinine 
 
Platelet count 
 
Hemoglobin and hematocrit 
 
Within 24 hours of the procedure, obtain an INR for subjects on 
warfarin 
 
Pregnancy test, as applicable to institution’s standard of care. 
 
Medication regimen: anticoagulant / antiplatelet agents taken within 24 
hours prior to index procedure. 
7.4.2. Intra-Operative  
For consented subjects that meet the pre-operative eligibility criteria, record the 
relevant data regarding their endovascular procedure.  
Prior to enrollment, record the following procedural information: 
 
ACT, if available based on institution’s standard of care, (for subjects 
receiving unfractionated heparin) 
 
anticoagulants and/or antiplatelet agents administered 
 
access site information, including angiographic assessment and antegrade 
access techniques employed 
 
diameter and length of the introducer sheath 
 
vessels treated during intervention 
 
contralateral access information, if applicable (e.g., prior to antegrade 
access but during index procedure) 
 
known planned staging of procedure, including minor amputation and 
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additional interventions prior to study exit. 
At the end of the endovascular procedure, with the procedural sheath in place 
and under fluoroscopic visualization, an injection of contrast will be made to 
assess the anatomy of the access site, the integrity of the procedural sheath (i.e., 
no kinking) and to verify the intra-operative eligibility criteria.   
NOTE: This image must be recorded and printed for the subject’s records.  
7.4.3. Access Site Closure 
The VASCADE Vascular Closure System should be deployed following the 
procedure in the Instructions for Use (IFU) provided in Attachment 2.  While the 
procedure is being performed, record the following information on the 
Procedure Source Data Worksheet provided by the Sponsor (required): 
 
T1: time antegrade access achieved (i.e., time of stick) 
 
T2: time endovascular procedure is completed (i.e., last guide catheter 
removed and final sheath is in place) 
 
T3: time of sheath fluoro/angio to confirm that procedural sheath placement 
is correct and not kinked (print for subject’s record) 
 
T4: time VASCADE VCS is inserted into the procedural sheath 
 
T5: time that VASCADE VCS was deployed and/or removed and adjunctive 
compression started* 
 
T6: time that arterial hemostasis was achieved 
 
Verification that arterial hemostasis was confirmed 5 minutes later 
 
Determination of Device Success 
 
Light compression methods implemented after TTH was achieved 
 
VASCADE VCS device specifications. 
*Immediate formation of a hematoma post-sheath removal may indicate a 
back-wall or secondary arterial puncture.  If this situation is suspected, the VCS 
should be removed and the subject should be converted to manual 
compression according to institution’s standard guidelines. 
Adjunctive Compression Guidelines: 
Upon successful deployment of the VASCADE VCS, adjunctive compression at 
the site may be used until arterial hemostasis is achieved (i.e., no pulsatile 
bleeding or a forming hematoma). TTH will not be recorded until adjunctive 
compression is no longer applied and arterial hemostasis is achieved. These 
times will be recorded on the Procedure Source Data Worksheet provided by 
the Sponsor (required). 
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NOTE: Manual compression devices should not be used for achieving initial 
arterial hemostasis to ensure accurate recording of TTH. 
 
Light Compression Guidelines: 
If the subject experiences slight oozing from cutaneous or subcutaneous tissues, 
characterized by the absence of pulsatile arterial flow, light compression 
methods (i.e., sand bags, compression bandages/devices, and light manual 
pressure) may be used to manage oozing.  Any light manual pressure applied to 
control oozing should be documented on the Source Document Worksheet. 
7.4.4. Post-Operative 
After hemostasis is achieved, the access site should be closely monitored at least 
every 15 minutes for the first hour, and then according to standard of care to 
confirm hemostasis. 
Ambulation 
Subjects should be ambulated according to institution’s standard practice. Any 
incidents of delay in ambulation (> 1 hour beyond stated standard of care for 
each site) should be documented on the Ambulation eCRF and a Protocol 
Deviation eCRF should be completed for non-medical delays > 1 hour. Record 
the following information on the Post-Procedure Source Data Worksheet 
provided by the Sponsor (required): 
 
T7 TTA: time that subject was able to stand and ambulate at least 20 feet 
without evidence of arterial re-bleeding at the access site. 
Hospital Discharge 
Prior to hospital discharge, all subjects will be evaluated for symptoms of lower 
extremity neuropathy in the ipsilateral limb that were not existing prior to the 
index procedure (i.e., paresthesias, numbness, weakness), including an 
assessment of severity. Record the following information on the Post-Procedure 
Source Data Worksheet provided by the Sponsor (required): 
 
T8 TTD: time of discharge from the facility. 
Subjects should be discharged according to institution’s standard practice. Any 
incidents of access site arterial re-bleeding, or delay in time to discharge should 
be documented on the Discharge eCRF.  
7.5. Follow-up 
All enrolled subjects are required to complete an office visit between days 1-15, 
and a 30 (+/- 7) day telephone follow-up. Depending on each institution’s 
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standard practice for follow-up visits, subjects may return to the office for access 
site assessment any time between 1 and 15 days post-procedure. The subject 
should be instructed that a follow-up telephone assessment will be conducted 
between day 23 and 37 to complete the study. It is important that all subjects are 
contacted within the 30 (+/- 7) day window to determine Procedural Success. 
During both the office visit and telephone follow-up, the subject should be 
queried regarding any complications they experienced after hospital discharge 
and the status of the access site wound should be assessed.  All subjects will be 
evaluated for symptoms of lower extremity neuropathy in the ipsilateral limb that 
were not existing prior to the index procedure (i.e., paresthesias, numbness, 
weakness), including an assessment of severity.  
In the event of refusal to return to the clinic, a protocol deviation will be reported 
and a telephone follow-up will be completed.   
7.6. Study Exit 
Once the subject has completed the follow-up visit or has withdrawn, they should 
be exited from the registry provided they do not have any conditions that require 
continued follow-up.  The date of exit and subject status will be recorded. 
8. Assessment of Procedural Outcomes 
8.1. Primary Procedural Outcomes - Performance 
Time to hemostasis (TTH) is defined as the elapsed time between Cardiva 
VASCADETM VCS removal and first observed and confirmed arterial hemostasis.  
The time to hemostasis will be measured in hour (hh):minutes (mm):seconds (ss).  
(TTH = T6 – T5). 
8.2. Secondary Procedural Outcomes - Performance 
Time to ambulation (TTA) is defined as elapsed time between device removal 
and when subject first stands and walks 20 feet without evidence of arterial re-
bleeding from the access site. The time to ambulation will be measured in hour 
(hh):minutes (mm).  (TTA = T7 – T5). 
Time to discharge (TTD) is defined as elapsed time between device removal and 
when subject is actually discharged from the facility. The time to ambulation will 
be measured in hour (hh):minutes (mm).  (TTA = T8 – T5). 
Device Success is defined as the ability to deploy the delivery system, deliver the 
collagen, and achieve hemostasis with the Cardiva VASCADETM VCS alone or 
with adjunctive compression. 
Procedure Success is defined as attainment of Device Success and freedom 
from major access site closure-related complications through 30 days. 
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8.3. Primary Procedural Outcomes - Complications 
The primary procedural complication composite to be evaluated is the 30-day 
patient incidence rate of combined major access site closure-related 
complications.  Major complications include: 
 
Access site closure-related bleeding requiring transfusion; 
 
Vascular injury requiring repair (via surgery, ultrasound guided compression, 
transcatheter embolization or stent graft); 
 
New ipsilateral lower extremity ischemia causing a threat to the viability of 
the limb and requiring surgical or additional percutaneous intervention; 
 
Access site-related infection requiring intravenous antibiotics and/or 
extended hospitalization; 
 
New onset neuropathy in the ipsilateral lower extremity requiring surgical 
repair; 
 
New onset permanent nerve injury in the ipsilateral lower extremity. (> 30 
days).  
8.4. Secondary Procedural Outcomes - Complications 
The secondary procedural complication composite to be evaluated is the 30-
day patient incidence rate of combined minor access site closure-related 
complications.  Minor complications include: 
 Access site-related bleeding requiring greater than 30 minutes to achieve 
initial arterial hemostasis; 
 Access site-related hematoma > 6 cm documented by ultrasound; 
 Late access site-related arterial bleeding requiring intervention (following 
hospital discharge); 
 Ipsilateral lower extremity arterial emboli documented by ultrasound/imaging; 
 Ipsilateral deep vein thrombosis documented by ultrasound; 
 Access site-related vessel laceration; 
 Access site wound dehiscence; 
 Localized access site infection treated with intramuscular or oral antibiotics; 
 Arteriovenous 
fistula 
not 
requiring 
treatment, 
documented 
by 
ultrasound/imaging; 
 Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; 
 New onset access site-related neuropathy in the ipsilateral lower extremity not 
requiring surgical repair. 
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9. Statistical Considerations 
9.1.  Analysis Populations and Data Handling Conventions   
9.1.1. Intent to Treat (ITT) Population 
All subjects who receive any portion of the Cardiva VASCADETM VCS device 
treatment under this protocol (i.e., intention to enroll acknowledged by 
Investigator prior to introduction of the device; subject is then enrolled at time of 
device introduction) will be included in the primary, ITT performance and 
complication analyses.  
Subjects who do not receive any portion of the VASCADETM VCS but instead 
receive manual compression, a VASCADE VCS commercial device (i.e., outside 
of the registry), or another approved closure device instead (i.e., by error or by 
Investigator choice), will not be enrolled and are therefore excluded from all 
analyses.  
9.1.2. Per Protocol (PP) Population 
As secondary analyses, all subjects who have the collagen deployed and meet 
all I/E criteria will be included in the PP performance and complication analyses. 
9.1.3. Missing Data 
Missing data will not be imputed by any method.  
9.2. Statistical Analysis Plan 
9.2.1. General Analysis Principles 
As a descriptive study, mean, standard deviation, median, minimum and 
maximum will be reported for continuous variables. Frequencies and proportions 
will be reported for categorical variables. Ninety-five percent confidence 
intervals will be reported for outcome summaries, e.g. mean and median for 
time to hemostasis (TTH), time to ambulation (TTA), and time to discharge (TTD), 
and Wilson score confidence intervals for proportions of device success and 
procedure success. 
Since the critical limb ischemia population encompasses a broad spectrum of 
disease severity and comorbidities, both performance and complication 
outcomes will be presented overall and by the following subgroups: Rutherford 
score < 5 vs. 6 (i.e., tissue loss), index intervention above knee v. at/below knee, 
gender, presence vs. absence of diabetes mellitus, BMI ≤ 30 vs. > 30, and 
inpatient vs. outpatient facility procedures. Additionally, TTA and TTD will also be 
presented overall and by no delay vs. delays related to the access site vs. 
delays due to other causes, as reported by the Investigator. 
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9.2.2. Performance Outcomes  
9.2.2.1.  Primary Performance Outcome Analysis (TTH) 
The primary performance outcome to be described is time to hemostasis (TTH) as 
defined in Section 8.1. Summary statistics for TTH (mean, standard deviation, 
median, minimum, and maximum) will be reported for the ITT and PP subject 
cohorts, and as described in Section 9.1. Ninety-five percent confidence 
intervals will be presented for means and medians. The proportions of enrolled 
Cardiva VASCADETM VCS subjects converted to manual compression will also 
be reported. 
9.2.2.3  Secondary Performance Outcomes Analyses 
Secondary performance outcomes to be reported include time to ambulation 
(TTA), time to discharge (TTD), and proportions of device success and 
procedure success as defined in Section 8.2 in both the ITT and PP cohorts. The 
analyses will be as described in Section 9.2.1. 
9.2.3. Complication Outcomes 
9.2.3.1.   Primary Complication Outcome Analysis 
The primary complication outcome analysis will be based on the 30-day 
patient incidence rate of combined major access site closure-related 
complications for the ITT and PP cohorts, as described in Section 9.1.  The 
proportion of subjects with any major access site closure-related complications 
will be reported with 95% Wilson core confidence intervals.  For each particular 
major complication listed in Section 8.3, the proportion of subjects reporting it 
will also be summarized. 
9.2.3.2.   Secondary Complication Outcome Analysis 
The secondary safety analysis will be based on the 30-day patient incidence 
rate of combined minor access site closure-related complications for the ITT 
and PP cohorts.  The proportion of subjects with any minor access site closure-
related complications will be reported with 95% Wilson core confidence 
intervals.  For each particular minor complication listed in Section 8.4, the 
proportion of subjects reporting it will also be summarized. 
Additionally, all reported adverse events will be summarized, and will be 
mapped to standard terms. The number and proportion of subjects reporting 
any given adverse event will be tabulated according to the worst severity 
reported up to the 30 day follow-up.  Separate tables will be constructed for (a) 
all reported adverse events, (b) device related adverse events, (c) serious 
device-related adverse events, and (d) all serious adverse events.   
 
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9.3. Sample Size Estimation 
As a descriptive study, the sample size was not derived for statistical comparisons.  
It is judged that 100 subjects will provide sufficient precision for the outcome 
parameters of interest.  
10. Data Management – Data Collection and Processing 
Standardized eCRFs will be utilized by all participating sites using an EDC platform. 
Investigators are responsible for the accurate completion and timely submission of 
the data collected during the registry.  All data from the registry will be entered 
into eCRFs via a secure, web-based system with password protection.  Incoming 
data will be automatically reviewed to identify inconsistent or missing data and 
any adverse events.  Any data issues are to be promptly addressed with the 
Investigator by the CRO.  Quality assurance procedures will be established to 
ensure that complete, accurate and timely data are submitted, that protocol 
requirements are followed and that complications, adverse events and adverse 
device effects are correctly reported and investigated, as appropriate.  
The Principal Investigator must maintain detailed records on all subjects who sign 
the Informed Consent and begin the pre-procedure evaluation. All data should 
be entered completely, promptly and legibly.  For source documents, corrections 
should be made in a manner that does not obscure or eliminate the original error, 
by striking through the original data with one line, and initialing and dating the 
change, along with the reason for the change (if not obvious).   
Study Exit eCRFs are completed for all enrolled subjects, regardless if they did or 
did not complete the registry (e.g., subject discontinuation, registry termination). 
11. Monitoring Procedures 
11.1. Monitoring  
Remote and on-site monitoring visits to the clinical sites will be made periodically 
during the registry, to ensure that all aspects of the current, approved 
protocol/amendment(s) and 21 CFR 50 requirements are followed. Original 
source documents will be reviewed for verification of data in the electronic 
database. The Investigator/institution guarantees direct access to original 
source documents by Cardiva Medical, Inc. personnel, their designees, and 
appropriate regulatory authorities. In the event that the original medical records 
cannot be obtained for a patient that is seen by a non-study physician at a non-
study institution, photocopies of the original source documents must be made 
available for review. 
It is important that the Investigator and relevant study personnel are available 
during the monitoring visits and that sufficient time is devoted to the process. 
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If a deficiency is noted during an on-site visit (or at any other time during the 
course of the registry), the clinical monitor is required to discuss the situation with 
the Investigator and the Sponsor (if required) to secure compliance. 
11.2. Commercial Device Distribution and Accountability 
11.2.1. Commercial Device Distribution 
Each site will be responsible for ordering commercial product to be used in the 
registry. The Investigator is responsible for ensuring that the devices are 
available at the hospital before the procedure date.  
11.2.2. Device Accountability 
Device information will be collected in the eCRF (e.g., size and lot#). Since the 
devices are commercially distributed, there are no device accountability 
requirements for this registry, however labels or other source data confirming 
the device information should be kept with the subject’s records for monitoring 
purposes.  
12. Quality Control and Quality Assurance 
12.1. Site Training 
To ensure accurate, complete, and reliable data, the Sponsor or its 
representatives will provide instructional material to the trial sites, as appropriate;  
 
Instruct the Investigators and site personnel on the protocol, the completion 
of the eCRFs, and registry procedures 
 
Communicate regularly with site personnel via mail, email, telephone, and/or 
fax 
12.2. Physician Training 
Investigators with significant experience in performing antegrade access and 
subsequent closure with VCDs were chosen to participate in this registry, 
therefore “roll-in” cases will not be performed in the registry. A Cardiva Medical 
representative may be present for the first several cases. All enrolling 
Investigators will be approved by Cardiva Medical, in writing, prior to their 
participation in the registry. 
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13. Adverse Events and Device Failure Reporting Requirements 
13.1. Regulatory Requirements – 21 CFR 803 Medical Device Reporting for 
Commercially Available Devices 
Cardiva Medical, Inc., or its designee, in cooperation with the Investigator, will 
assess all reported adverse events considered to be serious and device-related 
for potential reportability to the FDA according to 21 CFR 803 requirements. 
MDR reportable events are incidents that reasonably suggest that the VASCADE 
VCS, a) may have caused or contributed to a death or serious injury; or b) has 
malfunctioned and that the device or a similar device marketed by Cardiva 
Medical would likely cause or contribute to a death or serious injury if the 
malfunction were to recur.  
“Caused or contributed to” means that a death or serious injury was or may 
have been attributed to a medical device, or that a medical device was or 
may have been a factor in a death or serious injury, including events occurring 
as a result of: 
 
failure; 
 
malfunction, defined as the failure of a device to meet its performance 
specifications or otherwise perform as intended, according to approved 
labeling;  
 
improper or inadequate design; 
 
manufacture; 
 
labeling (i.e., IFU); 
 
user error. 
A “serious injury” means that an injury or illness which: 
 
Is life-threatening – substantial risk of dying at the time of the AE, or use or 
continued use of the device might have resulted in the death of a patient; 
 
Results in permanent impairment of a body function or damage to a body 
structure, excluding trivial impairment or damage (“permanent” means 
irreversible impairment, excluding trivial impairment or damage).  
 
Necessitates medical or surgical intervention to preclude permanent 
impairment of a body function or permanent damage to a body structure. 
Incidences requiring surgery to remove malfunctioned device will be 
considered a serious injury. Retrieval of a fracture piece from a body cavity 
without the need for additional medical intervention will not be considered a 
serious injury. 
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13.2. Reporting Guidelines 
13.2.1.  Serious Adverse Events or Injuries 
 
Complete Adverse Event eCRF within 24 hours of knowledge of any Serious 
Adverse Event.  
o Events will be categorized for seriousness by both Good Clinical Practice 
Guidelines (GCP), and by 21 CFR 803 MDR Reporting requirements. 
 
Complete device-related questions on AE eCRF. IF AE is marked as “Related to 
VCS”, an email notification will then be sent to Cardiva Medical Complaint 
Handling and to the CRO for follow-up. You may be prompted to complete a 
Device Performance/Complaint eCRF. 
 
Follow institution’s IRB adverse event reporting requirements, as applicable.  
13.2.2. Device Failures or Malfunction 
 
For any device performance issues occurring in this registry, whether an 
adverse event resulted or not, complete the Device Performance/Complaint 
eCRF within 24 hours of the observation. An email notification will then be sent 
to Cardiva Medical and to the CRO for follow-up. 
 
NOTE: Device failures or malfunctions are NOT to be reported as adverse 
events. However, if there is an adverse event that results from a device failure 
or malfunction, that specific event would be reported.  
 
For questions, contact: 
Cardiva Medical Customer Service 
Toll Free: (in the U.S.) 1-866-602-6099 
Toll Free Fax: (in the U.S.) 1-866-602-1795 
Email: complaint@cardivamedical.com 
13.3. Registry Reporting Requirements for Adverse Events  
The following adverse events must be reported in this post-market registry:  
 
serious, device-related adverse events (i.e., “reportable”) 
 
major or minor access site closure-related complications (serious and non-
serious), as defined in Section 8 
 
any adverse event that, in the Investigator’s opinion, is clinically significant 
AND is any one of the following: 
o device-related 
o access site-related 
o access limb-related. 
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1. Complete an Adverse Event eCRF within 24 hours of knowledge of a 
reportable event. Medical records (e.g., procedure notes, operative notes, 
discharge summary, relevant progress notes, imaging or lab studies) may be 
requested by Cardiva Medical or its designee for event review and potential 
adjudication.  
2.  For questions, contact Marlys Chellew at 916-303-0879. 
All required adverse events (AE) (serious and non-serious) will be recorded on 
the eCRF and monitored from the time of enrollment through study exit.  
 
In addition to 21 CFR 803 seriousness definitions, the following definitions for 
Serious Adverse Events will be used for consistency with published comparative 
data (per GCP, E6). 
A serious adverse event (SAE) is defined as an event which leads to:   
 
Death due to any cause 
 
Life-threatening condition 
 
Results in persistent or significant disability/incapacity 
 
Requires in-patient hospitalization or prolonged hospitalization 
 
Necessitates an intervention to prevent a permanent impairment of 
a body function or permanent damage to a body structure 
 
Results in congenital abnormality  
The following definitions for rating severity of adverse events will be used: 
Mild: 
Awareness of signs or symptoms, but easily tolerated; are of minor 
irritant type; causing no loss of time from normal activities; 
symptoms would not require medication or a medical evaluation; 
signs or symptoms are transient. 
Moderate: Interferes with the subject’s usual activity and/or requires 
symptomatic treatment. 
Severe: 
Symptom(s) causing severe discomfort and significant impact of 
the subject’s usual activity and requires treatment. 
14    Ethical Considerations 
14.1   Institutional Review Board Approval 
A copy of the protocol, proposed Informed Consent form, other written patient 
information and any proposed advertising material must be submitted to the IRB 
for written approval. A copy of the written IRB approval of the protocol and 
Informed Consent form must be received by Cardiva Medical, Inc. before the 
site initiation visit and recruitment of patients into the registry. 
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The Investigator must submit and, where necessary, obtain approval from the IRB 
for all subsequent significant protocol amendments and significant changes to 
the Informed Consent form.  Cardiva Medical may make certain administrative 
changes to the protocol without prior approval of the IRB.  Cardiva Medical will 
notify all investigative sites of such changes to ensure the study continues to be 
conducted consistently across all sties. The Investigator should notify the IRB of 
deviations from the protocol and/or SAEs occurring at the site in accordance 
with local requirements. 
The Investigator will be responsible for obtaining annual IRB/IEC approval and 
renewal throughout the duration of the study. Copies of the Investigator’s reports 
and the IRB/IEC continuance of approval must be sent to Cardiva Medical, Inc.  
14.2 Informed Consent Form – 21 CFR 50 Protection of Human Subjects 
A sample Informed Consent form is provided in Attachment 1 for the Investigator 
to prepare for use at his/her site. The written Informed Consent documents 
should be prepared in the language(s) of the potential patient population, and 
the final template approved by Cardiva Medical prior to IRB submission, to 
ensure compliance with applicable parts of 21 CRF 50. 
The reviewing IRB must first approve the Informed Consent forms that are used. 
All Protected Health Information (PHI) to be collected in the study will be 
described in the informed consent form, and all study data will be managed in 
accordance with the Privacy Law (HIPAA). 
Prior to participation in the registry, each patient must give written Informed 
Consent after the context of the registry has been fully explained to the patient 
in language that is easily understood by the patient. The patients must also be 
given the opportunity to ask questions and have those questions answered to 
their satisfaction. 
Written Informed Consent must be recorded appropriately by means of the 
patient’s dated signature. The patient will receive a copy of the Informed 
Consent form.  
14.3   Protocol Deviations 
A protocol deviation is defined as an event where the Investigator or site 
personnel did not conduct the registry according to the protocol. 
Due to the post-market nature of this registry, no waivers will be granted for 
inclusion/exclusion criteria. Subjects who do not meet all criteria may be treated 
commercially with the VASCADE VCS at the Investigator’s discretion, but shall 
not be enrolled in the registry.  
Deviations must be reported to Cardiva Medical regardless of whether 
medically justifiable, pre-approved by Cardiva Medical or taken to protect the 
subject in an emergency. Protocol deviations will be reported on the Protocol 
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Deviation case report form. Investigators will adhere to procedures for reporting 
study deviations to their IRB in accordance with their specific IRB reporting 
policies and procedures. 
14.4   Coverage of Expenses 
Subjects will not be reimbursed or compensated for participating in the registry. 
14.5 Confidentiality  
Confidentiality of subjects will be maintained throughout the registry.  A unique 
identification code will be assigned to each subject participating in this registry.  
Any data that may be published in abstracts, scientific journals, or presented at 
medical meetings will reference a unique subject code and will not reveal the 
subject’s identity.  The Sponsor and their CRO representative will make every 
reasonable effort to protect the confidentiality of the subjects participating in 
the registry. 
15  Administration 
15.1   Pre-Enrollment Documentation Requirements 
Prior to enrollment of subjects, the following documents must be provided to 
Cardiva Medical, Inc.: 
 
Fully executed Clinical Study Agreement 
 
Signed and dated Investigator Agreement/Protocol Signature Page for 
approved Investigators 
 
A copy of the written IRB approval of the protocol  
 
A copy of the written IRB approval of the Informed Consent Form  
 
A copy of the curriculum vitae of the Principal Investigator and Co-
Investigator (if applicable) 
15.2 Source Documentation 
The Principal Investigator must maintain detailed source documents on all 
subjects who are enrolled in the registry or who undergo screening.  Source 
documents include subject medical records, hospital charts, clinic charts, 
Investigator’s subject files, as well as the results of diagnostic tests (e.g., 
laboratory tests). 
The following minimum information should be recorded in the subject’s medical 
records: 
 
The date the subject entered the registry and the subject number 
 
The date that informed consent was obtained 
 
Evidence that the subject meets registry eligibility requirements (e.g., medical 
history, trial procedures and/or evaluations) 
 
The dates of all registry related subject visits 
 
Evidence that required procedures and/or evaluations were completed 
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 
Use of specified concurrent medications 
 
Documentation of specific device used 
 
Occurrence and status of applicable Adverse Events 
 
The date the subject exited the registry, and a notation as to whether the 
subject completed the registry or was discontinued, including the reason for 
discontinuation. 
15.3 Criteria for Terminating Study 
Cardiva Medical, Inc reserves the right to terminate the registry but intends only 
to exercise this right for valid scientific or administrative reasons. Investigators 
and associated IRB will be notified in writing in the event of termination. 
15.4 Criteria for Suspending/Terminating a Study Center 
Cardiva Medical, Inc. reserves the right to stop the enrollment of patients at a 
study center at any time after the site initiation visit if no patients have been 
enrolled or if the center has multiple or serious protocol violations without 
justification or fails to follow remedial actions. 
Possible reasons for suspending/terminating a center include: 
 
Repeated failure to complete electronic case report forms prior to 
scheduled monitoring visits. 
 
Failure to obtain written Informed Consent. 
 
Failure to report serious device-related injuries or device failures to Cardiva 
Medical, Inc. in accordance with 21 CFR 803. 
 
Failure to comply with the requirements of the protocol. 
 
Misuse of the VASCADE VCS (i.e., IFU not adhered to). 
15.5 Investigator Responsibilities 
 
Agree to sign and adhere to the Investigator Agreement 
 
Agree to obtain IRB approval of the protocol and consent form prior to 
enrolling subjects 
 
Agree to report serious, device-related injuries and deaths, as well as device 
failures in accordance with 21 CFR 803 (See Section 13) 
 
Comply with all required elements of this protocol (e.g., perform testing and 
follow-up as specified, compliance) and supply data suitable for quantitative 
analysis 
 
Agree to obtain written Informed Consent before any registry specific 
procedures are performed  
 
Complete all electronic data modules prior to scheduled monitoring visits 
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16 Publication Policy 
The data generated by this registry are the property of the Sponsor, Cardiva 
Medical, Inc., and should not be disclosed without their prior written permission.  
These data may be used by the Sponsor now and in the future for presentation or 
publication at Sponsor’s discretion or for submission to governmental regulatory 
agencies, if applicable.  The Principal Investigators may publish or present the 
registry results with prior consent of the Sponsor, but will not disclose confidential 
information.  Prior to submission by a Principal Investigator for publication or 
presentation, the Sponsor will be provided with the opportunity to review the 
submission for confidential information and accuracy. 
17 Responsibilities 
17.1 Role of Cardiva Medical 
As the Sponsor of this registry, Cardiva Medical has the overall responsibility for 
the conduct of the study, including adherence to applicable sections of Title 21 
CFR Part 50 - Human Subject Protection and for Medical Device Reporting 
according to Title 21 CFR Part 803 for commercial devices.  
Cardiva Medical is also responsible for obtaining signed study agreements, for 
providing the Investigators with adequate information and on-site training to 
conduct the registry, to ensure proper clinical site monitoring, and to provide the 
required reports to the Investigators and IRB’s, as applicable for this registry.  
In this registry, Cardiva Medical will have certain direct responsibilities and will 
delegate other responsibilities to Consultants.  Together, both Cardiva Medical 
and its Consultants will ensure adherence to these responsibilities. 
17.2 Monitoring  
The Sponsor and/or designee will conduct remote and on-site monitoring to 
ensure that all Investigators are in compliance with the protocol. The Sponsor 
and/or designee will monitor the sites to ensure that the completed Case Report 
Forms match the medical records, and resolve any differences.  
17.3 Maintaining Records  
The Sponsor and clinical sites will maintain copies of correspondence, data, 
serious adverse device effects and other records related to the registry for a 
period of two years after the registry is terminated or completed. 
18 Abbreviations and Definitions 
18.1 Abbreviations 
 
ACT 
Activated clotting time 
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AE 
Adverse Event 
AV 
Arteriovenous 
CFR 
Code of Federal Regulations 
eCRF 
Electronic Case Report Form 
CV 
Curriculum Vitae 
FDA 
Food and Drug Administration 
Fr 
French 
Hgb 
Hemoglobin 
Hct 
Hematocrit 
IFU 
Instructions for Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
LMWH 
Low molecular weight heparin 
MDR 
Medical Device Reporting (21 CFR 803) 
SAE 
Serious Adverse Event 
TTA 
TTD 
TTH 
Time to Ambulation 
Time to Discharge 
Time to Hemostasis 
18.2 Definitions 
ACCESS SITE-RELATED HEMATOMA > 6 CM 
A localized collection of extravasated blood in subcutaneous tissue at the 
access site measuring > 6 cm at its widest point, documented on ultrasound. 
ACCESS SITE CLOSURE-RELATED BLEEDING REQUIRING TRANSFUSION 
Bleeding originating from the index arteriotomy site, which has occurred to the 
degree that transfusion of blood products is necessary to maintain 
hemodynamic stability. 
ACCESS SITE-RELATED BLEEDING REQUIRING > 30 MINUTES TO ACHIEVE INITIAL 
HEMOSTASIS 
Bleeding from the arterial access site requiring greater than 30 consecutive 
minutes of standard compression to achieve initial arterial hemostasis. 
ACCESS SITE-RELATED INFECTION REQUIRING INTRAVENOUS ANTIBIOTICS AND/OR 
PROLONGED HOSPITALIZATION 
Must meet one of the following: 1) wound opened with excision of tissue (I&D); 2) 
positive wound culture requiring treatment with intravenous antibiotics; 3) 
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administration of intravenous antibiotics for access site-related infection based 
on medical judgement, even if wound culture is negative or not done, or 4) 
prolonged hospital discharge time directly related to complications of 
arteriotomy site infection.  Does not include administration of prophylactic 
antibiotic regimens. 
ACCESS SITE CLOSURE-RELATED NERVE INJURY 
New onset of functional disturbance and pathologic change in the ipsilateral 
peripheral nervous system.  May include transient loss of sensation, pain, 
numbness or tingling in the extremity; or transient loss of motor function. 
ACCESS SITE CLOSURE-RELATED VESSEL LACERATION 
A cut or tear to an arterial or venous vessel wall, requiring surgical or 
interventional repair. 
ACCESS SITE WOUND DEHISCENCE 
A separation of all layers of the access site wound. 
ADVERSE EVENT SEVERITY RATING 
Mild: 
Awareness of signs or symptoms, but easily tolerated; are of 
minor irritant type; causing no loss of time from normal activities; 
symptoms would not require medication or a medical 
evaluation; signs or symptoms are transient. 
Moderate: 
Interferes with the subject’s usual activity and/or requires 
symptomatic treatment. 
Severe: 
Symptom(s) causing severe discomfort and significant impact of 
the subject’s usual activity and requires treatment. 
ADJUNCTIVE COMPRESSION 
Moderate manual compression at the arteriotomy site immediately after 
VASCADE VCS deployment, applied as an adjunctive measure to facilitate TTH. 
Adjunctive compression time will be included in TTH; any light manual pressure 
held for tissue tract oozing should be documented separately. 
 
ALLERGIC REACTION  
A state of abnormal and individual hypersensitivity acquired through exposure to 
a particular allergen. 
APPROVAL (IN RELATION TO INSTITUTIONAL REVIEW BOARDS (IRBs) 
The affirmative decision of the IRB that the registry has been reviewed and may 
be conducted at the institutional site within the constraints set forth by the IRB, 
the institution, and the applicable regulatory requirements. 
ARTERIAL OCCLUSION 
Total obstruction of the artery by thrombus or other emboli requiring surgical or 
interventional repair, thrombolysis or percutaneous thrombectomy. 
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ARTERIAL / VENOUS THROMBOSIS 
Formation or development of a blood clot or thrombus, specifically in the arterial 
or venous system of the ipsilateral distal extremity. 
ARTERIOVENOUS (AV) FISTULA 
A connection between the access artery and the adjacent vein that is 
demonstrated by arteriography or ultrasound, most often characterized by a 
continuous bruit; diagnosis should be confirmed by angiographic or ultrasound 
imaging. 
CO-INVESTIGATOR / SUB-INVESTIGATOR 
An individual member of the investigation team designated and supervised by 
the Investigator at a registry site who enrolls subjects into the registry. Sub-
Investigators must be qualified by training and experience to participate, and 
must be approved by Cardiva Medical prior to enrolling subjects. See also 
Investigator.  
CONFIDENTIALITY  
Prevention of disclosure, to other than authorized individuals, of a Sponsor's 
proprietary information or of a subject's identity / Protected Health Information 
(PHI) in compliance with the Health Insurance Portability and Accountability Act 
of 1996 (HIPAA). 
DEVICE FAILURE / MALFUNCTION 
The failure of a device to meet its performance specifications or otherwise 
perform as intended. Performance specifications include all claims made in the 
labeling for the device. The intended performance of a device refers to the 
intended use for which the device is labeled or marketed.  
DEVICE SUCCESS  
Defined as the ability to deploy the delivery system, deliver the collagen, and 
achieve hemostasis with the Cardiva VASCADETM Vascular Closure System alone 
or with adjunctive compression. 
ELECTRONIC CASE REPORT FORM (eCRF) 
An electronic document designed to record all of the protocol-required 
information to be reported to the Sponsor on each subject. 
EMBOLISM 
The sudden blocking of an artery by a clot or other material that has been 
brought to its site of lodgment by the blood current (embolus).  Potential sources 
of emboli include blood clots, fat globules, air bubbles, tissue, clumps of 
bacteria, thrombus or foreign material. 
EMBOLIZATION OF DEVICE COMPONENTS 
Accidental deployment or dislodgement of any component of the Cardiva 
VASCADETM VCS into the bloodstream. 
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HEMATOMA 
A localized collection of extravasated blood in subcutaneous tissue, usually 
clotted.  A metric ruler should be used to measure the widest portion of the 
hematoma. 
HEMOSTASIS 
Cessation of common femoral artery bleeding (excluding cutaneous or 
subcutaneous oozing). 
INDEPENDENT PHYSICIAN ADJUDICTOR (IPA) 
An independent physician, qualified by training and experience in the field of 
interventional cardiology or radiology, who will review and adjudicate all 
reported adverse events that are both serious and device-related; and all 
reported major and minor access site closure-related complications.  The IPA is 
not a participant in the trial and is independent of Cardiva Medical. 
INFLAMMATION 
A localized protective response elicited by injury or destruction of tissues, not 
necessarily synonymous with infection. 
INFORMED CONSENT 
A process by which a subject voluntarily confirms in writing his or her willingness 
to participate in a particular investigation, after having been informed of all 
aspects of the investigation that are relevant to the subject's decision to 
participate.  Informed consent is documented by means of a written, signed, 
and dated Informed Consent form.  
INTERNATIONAL NORMALIZED RATIO (INR) 
A comparative rating of Prothrombin time (PT) ratios.  Used to measure 
coumadin efficacy in subjects. 
INTIMAL TEAR / DISSECTION 
Disruption of an arterial wall resulting in splitting and separation of the intimal 
(subintimal) layers. 
INVESTIGATIONAL SITE 
The location(s) where registry-related activities are actually conducted.  
INVESTIGATOR 
The person responsible for the conduct of the registry at a clinical site. The 
responsible leader of the team and may be called the Principal Investigator.  
See also Co-Investigator.  
IPSILATERAL 
Situated on or affecting the same side (e.g., same side of the body as the 
access site). 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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IPSILATERAL DEEP VEIN THROMBOSIS 
Presence of a thrombus in the peripheral venous system of the ipsilateral limb.  
May be a complication of phlebitis or may result from injury to a vein or from 
prolonged bed rest. Symptoms include a feeling of heaviness, pain, warmth, or 
swelling in the affected part; diagnosis should be confirmed by ultrasound 
imaging. 
IPSILATERAL LOWER EXTREMITY ARTERIAL EMBOLI 
Presence of emboli in the peripheral arterial system of the ipsilateral limb; 
diagnosis should be confirmed by angiographic or ultrasound imaging. 
LATE ACCESS SITE-RELATED ARTERIAL BLEEDING REQUIRING INTERVENTION (i.e., 
following hospital discharge) Re-bleeding from the puncture site following 
hospital discharge and up to 30 days post procedure that requires manual 
compression or other intervention to prevent a life-threatening event. 
 
LIFE-THREATENING ADVERSE EVENT 
A device-related injury in which the patient was at substantial risk of dying at the 
time of the adverse event, or use or continued use of the device might have 
resulted in the death of the patient. 
 
LOCALIZED ACCESS SITE INFECTION 
Infection occurring at the access site requiring treatment with oral or 
intramuscular antibiotic therapy.  Does not include administration of 
prophylactic antibiotic regimens. 
MANUAL COMPRESSION  
Direct digital non-occlusive pressure to the arteriotomy site applied to achieve 
hemostasis.  Note: C-clamp, FemoStop® , Sandbags and other methods are to 
be used only following the achievement of hemostasis for management of non-
arterial oozing/bleeding.   
MEDICAL DEVICE REPORTING REQUIREMENTS (MDR) 
21 CFR 803 Medical Device Reporting are the regulations that establish 
requirements for medical device reporting for device user facilities (i.e., hospital), 
manufacturers, importers and distributors regarding incidents where applicable 
commercially available devices may have caused or contributed to serious 
injury and death, and/or when the device malfunctions. The following definitions 
relate to 21 CFR 803 MDR requirements, also see Section 13: 
Caused or contributed:  
Means that a death or serious injury was or may have been attributed to 
a medical device, or that a medical device was or may have been a 
factor in a death or serious injury, including events occurring as a result of 
failure, malfunction, improper or inadequate design, manufacture, 
labeling, or user error. 
 
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Malfunction:   
Means the failure of a device to meet any of its performance 
specifications or otherwise to perform as intended.  Performance 
specifications include all claims made in the labeling of the device.  The 
intended performance of a device refers to the intended use for which 
the device is labeled or marketed through means such as labeling claims, 
advertising matter, and oral or written statements of Cardiva 
representatives. 
 
Medical Device Report (MDR):  
Means a report mandated by the FDA to be completed on FDA Form 
3500A regarding a reportable event. 
 
MDR Reportable Event:   
Any incident about which a Cardiva Medical employee receives or 
becomes aware of information that reasonably suggests that a Cardiva 
Medical device; (1) may have caused or contributed to a death or 
serious injury; or (2) has malfunctioned and that the device or a similar 
device marketed by Cardiva Medical would likely cause or contribute to 
a death or serious injury if the malfunction were to recur. 
 
Permanent: 
Means irreversible impairment or damage to a body structure or function 
excluding trivial impairment or damage. 
 
Reasonably Suggests: 
Means that a “reasonable” person considering the information would 
conclude that a reportable event has occurred.  Information which leads 
a person qualified to make a medical judgment (e.g. a physician, nurse, 
risk manager, clinical engineer, etc.) to reach a reasonable conclusion 
that a device-related event is or is not reportable is to be documented in 
the MDR event files. 
 
Serious illness or injury:  
Means an injury or illness that (1) is life-threatening; (2) results in permanent 
impairment of a body function or permanent damage to body structure; 
or (3) necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a 
body structure. Incidences requiring surgery to remove a malfunctioned 
device will be considered a serious injury.  Retrieval of a fracture piece 
from a body cavity without the need for additional medical intervention 
will not be considered a serious injury. 
 
NEW IPSILATERAL LOWER EXTREMITY ISCHEMIA  
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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New (acute) onset of compromised peripheral blood flow, causing a threat to 
the viability of the limb and requiring surgical or percutaneous intervention.  This 
compromised blood flow is documented by subject symptoms, physical exam 
and/or a decreased or absent blood flow on lower extremity angiogram. 
NEW ONSET ACCESS SITE CLOSURE-RELATED NEUROPATHY IN THE IPSILATERAL 
LOWER EXTREMITY REQUIRING SURGICAL REPAIR  
New onset access site closure-related nerve injury that requires surgical 
intervention to mitigate symptoms or prevent permanent nerve damage. 
NEW ONSET ACCESS SITE CLOSURE-RELATED NEUROPATHY IN THE IPSILATERAL 
LOWER EXTREMITY NOT REQUIRING SURGICAL REPAIR  
New onset access site closure-related nerve injury that does not require surgical 
intervention to mitigate symptoms or prevent permanent nerve damage, 
however is evaluated to be moderate to severe in nature by the Investigator 
(see “Adverse Event Severity Rating”). 
OOZING 
Minimal bleeding of a cutaneous or subcutaneous origin characterized by the 
absence of pulsatile arterial flow and controlled with the application of light 
compression methods (sand bags, pressure dressings, and light manual 
pressure).  Note:  the occurrence of oozing will not be incorporated into the 
“time to hemostasis” measurement. 
PERFORATION OF VESSEL WALL 
A hole or break in the arterial wall (e.g., from insertion of a percutaneous 
device). 
PERIPHERAL PULSE ASSESSMENT SCALE  
0 = absent; not palpable; 1 = diminished; 2 = expected; 3 = full, increased; 4 = 
bounding. 
PERIPHERAL VASCULAR DISEASE 
Damage to or dysfunction of the arteries outside the heart resulting in reduced 
blood flow; especially: narrowing or obstruction (as from atherosclerosis) of an 
artery (as the iliac artery or femoral artery) supplying the legs that is marked 
chiefly by intermittent claudication and by numbness and tingling in the legs. 
 
PERMANENT ACCESS SITE CLOSURE-RELATED NERVE INJURY (> 30 DAYS) 
New onset access site closure-related nerve injury that persists for > 30 
consecutive days following device removal and is evaluated to be moderate to 
severe in nature by the Investigator (see “Adverse Event Severity Rating”). 
 
PROCEDURE SUCCESS  
Defined as attainment of Device Success and freedom from major vascular 
complications through 30 days. 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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PSEUDOANEURYSM 
A blood vessel abnormality resembling an aneurysm (localized abnormal 
dilatation of a blood vessel) but consisting of a collection of blood with persistent 
flow outside an artery, contained by surrounding tissue and due to a leaking 
hole through all layers of the arterial wall.  The leaking hole is due to injury of 
(e.g., rupture of or trauma to) the arterial wall.  The pseudoaneurysm should be 
confirmed by angiography or ultrasound.  
 
2 levels of severity: 
o Requiring thrombin injection or fibrin adhesive injection to contain 
the leak 
o Not requiring treatment  
RE-BLEEDING 
Arterial bleeding from the puncture site occurring after initial hemostasis has 
been confirmed. 
REPORTABLE EVENT 
See SERIOUS ADVERSE EVENT 
 
RETROPERITONEAL BLEEDING/HEMATOMA 
Bleeding from an injured vessel, with deposition of blood into the retroperitoneal 
space (between the peritoneum and the posterior abdominal wall). 
RUTHERFORD CLASSIFICATION 
A commonly used clinical staging system for describing peripheral arterial 
disease, similar to the Fontaine classification. There are seven stages: 
 
1. Stage 0 – Asymptomatic 
2. Stage 1 – Mild claudication 
3. Stage 2 – Moderate claudication 
4. Stage 3 – Severe claudication 
5. Stage 4 – Rest pain 
6. Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot 
7. Stage 6 – Severe ischemic ulcers or frank gangrene 
 
SERIOUS ADVERSE EVENT (SAE)  
A “serious injury” which must be reported to FDA is a device-related death or a 
device-related injury as defined in 21 CFR 803, which: 
 
Results in death; 
 
Is life-threatening – substantial risk of dying at the time of the AE, or use or 
continued use of the device might have resulted in the death of a patient; 
 
Results in permanent impairment or damage to a body structure of function, 
excluding trivial impairment or damage  
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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 
Necessitates medical or surgical intervention to preclude permanent 
impairment of a body function or permanent damage to a body structure 
 
SUB-INVESTIGATOR / CO-INVESTIGATOR 
Any individual member of the clinical investigation team designated and 
supervised by the Investigator at an investigational site who performs critical 
investigation-related procedures and/or makes important investigation-related 
observations.  See also Investigator.  
SUBJECT 
An individual who participates in a clinical investigation. 
THROMBUS FORMATION 
Blood clot formation. 
VASCULAR INJURY REQUIRING REPAIR 
Injury to the access site arterial wall or adjunct venous vessel wall resulting in 
persistent bleeding and requiring repair (via surgery, angioplasty, ultrasound-
guided compression, transcatheter embolization or stent graft). 
VASOVAGAL EPISODE 
A transient vascular and neurogenic reaction marked by pallor, nausea, and/or 
sweating symptoms, bradycardia and rapid fall in blood pressure, which may 
lead to a loss of consciousness and ECG changes.  
VASOSPASM 
The sudden, but transitory constriction of a blood vessel, potentially causing 
discomfort and limitation of distal blood flow. 
WOUND SITE PAIN 
Local discomfort at the arteriotomy site which may range from mild to severe. 
18.3 Bibliography 
 
1. Hermiller J, Leimbach W, Gammon R. A prospective, randomized, pivotal trial of 
a novel extravascular collagen-based closure device compared to manual 
compression in diagnostic and interventional patients. J Invasive Cardiol 
2015;27(3):129-136. 
2. Biondi-Zoccai GG, Agostoni P, Sangiorgi G, et. al. Mastering the antegrade 
femoral artery access in patients with symptomatic lower limb ischemia; learning 
curve, complications, and technical tips and tricks. Catheter Cardiovasc Interv 
2006;68(6):835-42. 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
CARDIVA Medical, Inc. – ANTEGRADE-PVD REGISTRY 
 
 
 
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50 
 
 
3. Boschewitz JM, Pieper CC, Andersson M, et. al. Efficacy and time-to-ambulation 
of antegrade femoral access closure using the ExoSeal vascular closure device: 
a retrospective single-center study.  Eur J Vasc Endovasc Surg (2014) 48, 585-591. 
4. Gutzelt A, van Shie B, Schoch E, et. al. Feasibility and safety of vascular closure 
devices in an antegrade approach to either the common femoral artery or the 
superficial femoral artery. Cardiovasc Intervent Radiol (2012) 35:1036-1040. 
5. Maxien D, Behrends B, Berhardt KM, et. al. Evaluation of the 6-F ExoSeal vascular 
closure device in antegrade femoral artery punctures. J Endovasc Ther 
2012;19(6):836-43. 
6. Schmelter C, Liebl A, Vorwerk D, et. al. Suitability of Exoseal vascular closure 
device for antegrade femoral artery puncture site closure. Cardiovasc Intervent 
Radiol (2013) 36:659-668. 
7. Lupattelli T, Tannouri F, Garaci FG, et. al. Efficacy and safety of antegrade 
common femoral artery access closure using the Angio-Seal device: Experience 
with 188 interventions for critical limb ischemia in diabetic patients. J Endovasc 
Ther 2010; 17:366-375. 
8. Chui AH, VanderWal R, Tee K, et. al. Comparison of arterial closure devices in 
antegrade and retrograde punctures. J Endovasc Ther 2008;15(3):315-21. 
9. Minko P, Katoh M, Graber S, et. al. Obesity: An independent risk factor for 
insufficient hemostasis using the AngioSeal Vascular Closure Device after 
antegrade puncture. Cardiovasc Intervent Radiol (2012) 35:775-778. 
10. Kapoor B, Panu A, Berscheid B. Angio-Seal in antegrade endovascular 
interventions: technical success and complications in a 55-patient series. J 
Endovasc Ther 2007;14:382-386.  
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
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19 Attachment 1: Sample Informed Consent Form 
 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

 
CARDIVA Medical, Inc. – ANTEGRADE-PVD REGISTRY 
 
 
 
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20 Attachment 2: Instructions For Use (IFU) 
  
 
DocuSign Envelope ID: 803CE783-493B-4AA1-B596-A2FADC49BBE8

Rev 1 31OCT2016                                            Page 1 of 8 
Participant Sample Consent Form  
 
Title of Study: ANTEGRADE-PVD Post-Market Registry 
 
A MULTI-CENTER, PROSPECTIVE, POST-MARKET REGISTRY TO EVALUATE PROCEDURAL OUTCOMES 
DATA USING THE CARDIVA VASCADETM VASCULAR CLOSURE SYSTEM (VCS) FOR THE 
MANAGEMENT OF THE FEMORAL ARTERIOTOMY AFTER PERCUTANEOUS ENDOVASCULAR 
PROCEDURES VIA AN ANTEGRADE APPROACH 
 
 
Sponsor:  Cardiva Medical, Inc., Santa Clara, CA 
Principal Investigator: [add] 
Institution:  [add] 
Your Consent 
You are invited to take part in this registry at (insert hospital / facility name). A “registry” 
is a place where official records are collected and kept. The purpose of this “registry” is 
to collect procedural data when the Cardiva Medical VASCADETM Vascular Closure 
System (VCS) device is used to close the artery that will be punctured using a specific 
technique, as part of your upcoming procedure.  
 
This device was approved by the U.S. Food and Drug Administration (FDA) in January, 
2013, and has been used and sold in the United States since that time. The Cardiva 
Medical VASCADE VCS is not investigational. 
 
This consent form will provide you with information about the registry, the procedures 
that will be performed, and your rights. This consent form may contain words that you 
do not understand. Please ask the study doctor or the study staff to explain any words 
or information that you do not clearly understand.   
 
Purpose & Background of the Registry 
Your doctor has explained to you that you need a procedure to look at the arteries 
(blood vessels) in your legs and possibly treat them.  At the beginning of this procedure, 
the doctor will puncture a hole in an artery in your groin area, in order to look at the 
arteries in your leg on x-ray.  The doctor will make the hole on the same side of your 
body as the leg that needs to be treated. This is a technique called “antegrade 
access”, which means “in the direction of the blood flow”. This is one of several 
techniques that your doctor can decide to use for your procedure, based on his/her 
medical opinion about risks and benefits specific to your case. Your doctor’s decision 
that you need the procedure and use of an antegrade technique is made based on 
your medical needs and independent of this registry. 

Rev 1 31OCT2016                                            Page 2 of 8 
Once the doctor has finished any treatment of your leg arteries this hole will need to be 
sealed (closed up) to prevent bleeding. There are several FDA approved devices that 
could be used to close the hole, and the Cardiva Medical VASCADE VCS is one such 
device..  
Your doctor already uses this device to close holes in both “antegrade” and other types 
of cases, but there have not been many studies to collect data about antegrade 
procedures. The purpose of this registry is to collect data about your procedure so that 
the results can be provided for other health care professionals to use when making 
decisions about what procedures and devices to use in their patients.  
If you choose to take part in the registry, you will receive the Cardiva Medical device, 
providing your doctor feels you meet the study criteria. A small collagen (cotton-like) 
patch is placed just outside of the artery to plug the hole and stop the bleeding. The 
patch is absorbed by the body (dissolves) in about three months.  
Your doctor will do everything the same way he/she would if you were not in a study, 
except he/she will collect specific information about your procedure and information 
about how your are doing for about 30 days afterwards. 
If your doctor decides that you do not meet registry criteria, you may still receive a 
Cardiva Medical VCS outside of the registry, but you would not be enrolled in the 
registry. Your doctor may also decide that using an antegrade approach and/or using 
a Cardiva Medical VCS is not the best option for you. In those cases, you will not be 
enrolled in the registry and may receive another commercially available device, or you 
may have firm pressure placed on the leg artery hole for the amount of time it takes for 
the artery to clot and stop bleeding. This is known as “manual compression” and is also 
a usual way of treatment.   
This study will enroll about 100 patients at up to 7 hospitals in the United States.   
 
Procedures 
This study will last 30 days (± 7 days). The expected total time for all patients to 
complete the study is about 9 months.  If you agree to be in this registry, the following 
will happen to you: 
Pre-Procedure 
Before the operation you will have a medical interview and 
physical to make sure you qualify for the registry (are eligible to 
take part). Any blood that is taken will be done as part of your 
standard care, and there are no tests done specifically for the 
registry. 
Procedure 
During the operation your doctor will insert a small plastic tube to 
gain access to the large artery in your leg (femoral artery) using the 
“antegrade” technique.  He/she will then insert a small tube and 
inject dye to evaluate any blockages in your arteries on the same 
side of the body. It is possible that he/she might open a blocked 

Rev 1 31OCT2016                                            Page 3 of 8 
artery if he/she feels this is necessary during your procedure.  
He/she will also monitor your blood to determine how long it takes 
you to stop bleeding. 
 
When your doctor is finished with the operation and your doctor 
feels it is okay for you to take part in the registry, he/she will use the 
VASCADETM VCS to close the hole in the artery. This is when you 
would be “enrolled” as a subject in the registry and details about 
your procedure will be collected for the registry. 
Post-Procedure 
After the procedure, the puncture site (place where the hole was 
made for the tube) will be checked often to make sure it is not 
bleeding. Your doctor will determine how long you need to stay in 
bed, when you can walk and when you can be discharged based 
on his/her normal care for this type of procedure.    
Office Visit between 1-15 Days 
 
You will need to come in to your doctor’s office some time 
between 1 – 15 days after the procedure to be checked. Your 
doctor will check the place where the hole was in your leg to make 
sure it has healed properly, and will ask you questions about any 
problems you may have had.   
This type of visit is normal care for your procedure, and will be 
scheduled according to your doctor’s preferred timing for the visit.  
Phone Visit between 23 - 37 days 
You will be called on the phone by your doctor’s office within 
about 23 – 37 days after the procedure to check if you have any 
problems and that your leg has continued to heal properly.  This is 
done to make sure that all patients in the study are followed for at 
least 23 days, according to the protocol. 
Possible Risks  
 
The safety of this device has been tested and proven in several previous research 
studies of over 350 human patients without serious problems or deaths. The collagen 
patch is similar to other collagen-based closure devices used in surgery to close small 
holes.  In a large FDA approval study, a total of 417 subjects were enrolled. Two-thirds 
(275 patients) received the VASCADE device, and one-third (142) received manual 
compression to close the artery hole. Safety results were similar in both groups. Of the 
possible side effects listed below, there were no reports of these occurring in the 275 
VASCADE patients, except for the following: 
 
*Reported in < 1% of patients receiving VASCADE 
**Reported in < 2% of patients receiving VASCADE 

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***Reported in < 2.5% of patients receiving VASCADE 
 
 
Possible side effects (problems) are similar to other closure devices and “manual 
compression” and can include: 
 
• 
allergic response (to the material in the device or collagen) 
• 
arterial occlusion (blockage of the leg artery) 
• 
arterial thrombus (blood clot in the leg artery) 
• 
arterio-venous fistula (abnormal connection between artery and vein)* 
• 
death 
• 
device failure / malfunction*** 
• 
edema (swelling in the tissues) 
• 
embolization (thrombus, air, tissue, device floating downstream) 
• 
groin bruising*  
• 
groin hematoma (bleeding under the skin)** 
• 
groin inflammatory response (inflammation) 
• 
groin wound dehiscence (separation of wound edges) 
• 
intimal tear / dissection (tear of the leg artery wall) 
• 
limb ischemia (lack of oxygen to the leg) 
• 
mild infection or infection of the groin requiring extended hospital stay and IV 
antibiotic administration  
• 
minor bleeding* and/or bleeding requiring transfusion 
• 
peripheral nerve injury (nerve damage to the leg)* 
• 
perforation of the vessel wall (puncture of the vessel wall) 
• 
pseudoaneurysm (abnormal collection of blood with persistent flow outside 
an artery due to a leaking hole in the artery due to injury)** 
• 
retroperitoneal bleeding (bleeding in the pelvis)* 
• 
thrombus formation (blood clot in an artery or a vein)** 
• 
vasospasm (spasm of the artery) 
• 
vasovagal response (slowed heart rate with possible fainting) 
• 
vascular injury requiring repair (vessel damage requiring repair)  
• 
Wound site pain*** 
 
 

Rev 1 31OCT2016                                            Page 5 of 8 
There are other general risks that are associated with your entire procedure, and your 
doctor will tell you about those separately. 
 
The risks to an unborn baby conceived during the registry are unknown. Therefore, 
women in the registry should practice acceptable pregnancy prevention methods 
during the registry. Pregnant or lactating women cannot take part in the registry. 
However, breastfeeding women may decide to stop nursing, after discussing it with their 
physician, in order to take part in the registry. 
 
Unknown risks: The risks of placing a vascular closure device are understood. However, 
there may be additional risks, which are unknown at this time. 
 
Possible Benefits 
 
There is no guarantee or promise that you will receive any benefits from this registry. 
Potential benefits include rapid closure of the artery hole, which may increase your 
comfort after the procedure and may allow you to start walking sooner.  The doctors 
may learn more about how this device performs in cases where an “antegrade” 
technique is used.  There may also be other unexpected benefits that will be 
discovered as a result of this registry, and any new significant information will be 
provided to you by your doctor. 
 
Financial Responsibility  
 
You are not expected to pay any costs associated with participation in this registry. The 
registry does not require any tests that are not part of normal care. The Sponsor will pay 
your doctor for his/her time required to collect the data for the purpose of this registry. 
You or your insurance will be responsible for all costs for regular treatment. You will not 
be paid for your participation in this clinical trial, and there is no financial reward or 
compensation in any form.  
 
Compensation for Injury 
 
In the event that you become ill or injured as a result of your taking part in this registry, 
the Hospital will provide you with medical treatment. If it is determined that your illness 
or injury resulted from the collagen patch (VASCADE™ VCS) in your leg, this medical 
treatment, as well as other reasonable and customary medical expenses, will be paid 
for by the Sponsor of the registry (Cardiva Medical), but only to the extent that the costs 
and expenses are not covered by your health insurance or a government program. This 
agreement to provide free medical treatment does not include costs and expenses for 
an illness or injury that does not result from the collagen patch (VASCADE™ VCS). No 
funds have been set aside to compensate you for such injuries. In addition, the Sponsor 
of the registry has not set aside funds to compensate you for non-direct damages such 
as lost wages, disability, or discomfort due to illness or injury. No compensation or 
reimbursement is available from (insert institution) or the Sponsor.  
 
If you have any questions concerning the availability of medical care or if you think you 
have experienced a research related illness or injury, you should contact the research 

Rev 1 31OCT2016                                            Page 6 of 8 
study doctor or other research study staff. The study doctor and Sponsor will determine 
if the illness or injury may have resulted from the collagen patch you may have 
received. 
 
You will not waive your legal rights by signing this document. For instance, your legal 
right to claim compensation for illness or injury where you can prove negligence or 
malpractice will not be affected when you sign this form. 
 
 
Privacy, Confidentiality & Disclosure of Information 
 
Your confidentiality will be maintained in accordance with the privacy laws of the 
United States and the privacy and relevant health records laws of (insert 
state/providence). You have a right of access to, and to request correction of, 
information held about you by (insert facility name).  Any information obtained in 
connection with this registry project that can identify you will remain confidential and 
will only be used for the purpose of this registry.  It will only be disclosed to parties listed 
below with your permission, except as required by law.  
 
During the registry only your initials and a unique study number will be used to identify 
you. Your name, address and any other personal information will not appear on any 
documents that are collected in relation to this registry. It will not be possible to identify 
you from information in any publication resulting from this registry and every effort will 
be made to keep your own personal medical data confidential to the extent allowed 
by law. 
 
By signing this consent form you agree that under direction of the study doctor, 
authorized representatives of the Sponsor, Cardiva Medical, Inc. (the manufacturer of 
the registry device), and the Institutional Review Board can access your health 
information in order to conduct the registry. Although this registry is not governed by the 
United States Food and Drug Administration (FDA), the FDA may request access to your 
health information related to this registry at any time. 
 
Cardiva Medical or its representative may also send health information about you to its 
data management unit located in the U.S.A. By signing the attached Consent Form, 
you authorize release of, or access to, this confidential information to the relevant study 
personnel and regulatory authorities as noted above.  
 
A description of this registry will be available on http://www.ClinicalTrials.gov.  This web 
site will not include information that can identify you.  At most, the Web site will include 
a summary of results.  You can search the Web site at any time. 
 
All records kept from the registry may be destroyed after 2 years, unless Cardiva 
Medical requests otherwise.  
 
New Information Arising During the Project 
 

Rev 1 31OCT2016                                            Page 7 of 8 
During the registry, new information about the risks and benefits of the project may 
become known to the researchers. If this occurs, you will be told about this new 
information.  
 
Termination of the Registry 
 
This registry may be stopped for a variety of reasons. These may include reasons such as 
unacceptable side effects, or decisions made in the commercial interests of the 
Sponsor.  
 
Right of Refusal and Alternative Treatments 
 
Participation in this registry is voluntary.  You may refuse to participate in this registry or 
discontinue participation at any time.  If you refuse to participate in this registry, it will 
not affect the care your doctor will provide to you.  There are other treatments that are 
available to you including other closure devices and standard manual compression. 
 
Also, your Study doctor or the Sponsor may terminate your participation in the registry at 
any time, for reason, including these:  
• 
You have not followed the instructions of your study doctor and/or study staff  
• 
You become pregnant 
• 
You need treatment not allowed in the registry 
• 
The Sponsor decides to end the registry 
• 
Other unexpected circumstances 
 
Inquiries 
 
There are some technical terms used in this consent form.  If there is anything you do 
not understand, please ask your doctor or study nurse to explain.   
 
In case of emergency, or if you have any questions during this registry about your rights 
as a registry participant or the procedure, please contact:  
 
(add investigator name)    
(insert contact info) 
(add sub-investigators) 
(insert contact info) 
 
 
(add coordinators) 
(insert contact info) 
 
 
 
 
 
Consent 
 
 
Your signature below indicates that: 
• 
You have read and understood the above information. 
• 
You have discussed the registry with your study doctor. 

Rev 1 31OCT2016                                            Page 8 of 8 
• 
You have had a chance to ask all of your questions and have had them 
answered. 
• 
You have decided to take part in the registry based on the information 
aprovided. 
• 
A copy of this form has been given to you. 
 
 
 
 
_____/_____/_____ 
Signature of Participant  
 
Date  
 
 
 
 
Printed Name of Participant  
 
 
 
 
 
 
_____/_____/_____ 
Signature of Person Conducting Informed Consent 
 
Date  
 
 
 
 
Printed Name of Person Conducting Informed Consent 
 
 
 

Page 1 of 16 
 
  
VASCADEVascular Closure System (VASCADE VCS) 
INSTRUCTIONS FOR USE 
5F and 6/7F 
IFU 2611 Rev N 
 
CAUTION ± Federal (USA) law restricts this device to sale by or on the order of a physician 
DESCRIPTION 
The VASCADE VCS is intended to seal the femoral arterial 
access site at the completion of an endovascular procedure.  The 
system is designed to deliver a resorbable Collagen Patch, extra-
vascularly, at the arteriotomy site to aid in achieving hemostasis.  
There are two versions of products in the VASCADE product 
family. One is for use in 5F 12cm11 introducer sheaths, and the 
other device is for use in 6F or 7F 12cm1 introducer sheaths. 
The system consists of a sterile disposable Vascular Closure 
Catheter which houses a resorbable Collagen Patch, and the 
VASCADE Clip (refer to Figure 1). The collagen patch is 
composed of type I Bovine collagen and is delivered in a 
compressed form that is approximately 15mm in length.  The dry 
weight of the collagen in VASCADE 5F is 8.5mg ± 2mg and in 
VASCADE 6/7F it is 12mg ± 3mg.   The patch expands as a 
result of rehydration in the presence of blood in the tissue tract 
to provide an extravascular seal.  A radiopaque proximal marker 
band on the Catheter provides means to verify placement of the 
patch in the tissue tract adjacent to the femoral arteriotomy site 
prior to the release of the patch.  A second distal marker band 
locates the distal tip of the VASCADE Disc. After completion of 
the catheterization procedure, the VASCADE VCS Catheter is 
inserted through a commercially available 5F, 6F, or 7F 
introducer sheath.  The VASCADE Disc is then deployed within 
the vessel and the introducer sheath is removed over the 
VASCADE   VCS Catheter.  After the introducer sheath is 
removed, the VASCADE Disc is positioned against the intimal 
aspect of the arteriotomy, providing both temporary hemostasis 
and protection from intravascular placement of the Collagen 
Patch, and the VASCADE Clip is applied at skin level to maintain 
the position of the VASCADE Disc. After confirming the position 
of the Collagen Patch fluoroscopically, the Black Sleeve is 
unlocked and retracted to expose the Collagen Patch to the 
tissue tract. The system is left in place for a brief dwell period to 
allow the patch to swell, after which the VASCADE Disc is 
collapsed and the VASCADE VCS Catheter is removed from the 
artery 
leaving 
the 
resorbable, 
extra-vascular, hemostatic 
Collagen Patch at the arteriotomy site providing arterial 
hemostasis. 
 
 
INDICATIONS FOR USE 
The VASCADETM Vascular Closure System (VCS) is indicated for femoral arterial access site closure while reducing times 
to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using 
a 5F, 6F, or 7F procedural sheath. The VASCADE VCS is also indicated to reduce time to discharge eligibility in patients 
who have undergone diagnostic endovascular procedures using a 5F, 6F, or 7F procedural sheath. 
                                                 
1 Overall length of the sheath (including the hub) needs to be less than 15cm. 
Fig. 1 – VASCADE Vascular Closure System (VCS) 

Page 2 of 16 
CONTRAINDICATIONS 
The VASCADE VCS should not be used in patients with a known allergy to bovine derivatives. 
 
WARNINGS 
x 
Do not reuse or re-sterilize. The VASCADE VCS is intended to be used once only for a single patient. Product reuse 
or re-sterilization, may result in transmission of infectious or blood borne diseases and/or death. 
x 
Do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has 
been previously opened.  Damaged or opened packages may compromise product functionality. 
x 
Do not use if product is beyond the expiration date.  Product performance has not been established beyond the 
labeled shelf life. 
x 
Do not deploy the VASCADE Disc in a stent. Do not pull the deployed VASCADE disc through a stent.  Damage to 
the product may occur. 
x 
Do not use VASCADE if access is through a previously placed permanent closure device such as a metal clip.  
Interference between the two closure devices may result. 
x 
Do not deploy the Collagen Patch if there is a suspicion that the VASCADE Vascular Closure Disc is not seated 
against the intimal aspect of the arteriotomy site.  Partial or complete obstruction of blood flow may result. 
x 
Do not deploy a second collagen patch at the same access site within 90 days.  Safety has not been established. 
 
PRECAUTIONS 
x 
The VASCADE VCS should only be used by a trained licensed physician or healthcare professional. 
x 
Do not use in access sites where there is suspicion of a “backwall” stick.  Increased bleeding risk may occur. 
x 
Do not use if arteriotomy is noted to be a “side stick.”  Bleeding risk may increase. 
x 
Do not use if arteriotomy site is noted to be “high,” above the Inguinal Ligament (cephalad to lower half of the 
femoral head or the inferior epigastric artery origin from the external iliac artery).  This may increase the risk of 
bleeding. 
x 
Do not use in an artery with suspected intraluminal thrombus, hematoma, pseudoaneurysm, or arteriovenous 
fistula.  These conditions may complicate proper device use and performance. 
x 
Do not use if intra-procedural bleeding around the introducer sheath is noted including hematoma formation (sign 
of possible multiple wall stick).  This may suggest problems with the access site. 
x 
Do not use in a procedural sheath > 12cm in length (or >15cm in overall length) or with a diameter other than 5F 
for VASCADE 5F, or 6F or 7F for VASCADE 6/7F. This may complicate disk deployment. 
 
SPECIAL PATIENT POPULATIONS 
NOTE: The safety and effectiveness of VASCADE VCS have not been evaluated in the 
following patients who are/have: 
x 
Less than 18 years of age; 
x 
Pregnant and/or lactating women; 
x 
Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 
x 
Known significant coagulopathy/bleeding disorder such as thrombocytopenia (platelet count <100,000/mm!), 
thrombasthenia, hemophilia, von Willebrand’s disease or anemia (Hemoglobin <10g/dL, Hematocrit <30%); 
x 
Previous vascular grafts or surgery at the target vessel access site; 
x 
Symptomatic ipsilateral lower extremity ischemia; 
x 
Fluoroscopically visible calcium or atherosclerotic disease within 1 cm of the puncture site; 
x 
Femoral artery lumen less than 6 mm; 
x 
Length of the tissue tract, the distance between the anterior arterial wall and skin, is estimated to be less than 
2.5cm; 
x 
INR ≥1.8 if patient received warfarin; 
x 
Fibrinogen level < 150 mg/dl if patient received fibrinolytic agent; 
x 
Extreme morbid obesity (BMI > 45 kg/m2) or underweight (BMI < 20 kg/m"); 
x 
Uncontrolled hypertension (BP > 180/110); 
 
 

Page 3 of 16 
Adverse Events 
Complications may occur and may be related to the endovascular procedure or the vascular closure. They include, but 
are not limited to: 
x Allergic response 
x Embolization tissue,  
x Laceration of the vessel wall 
x Arterial occlusion 
(thrombus, air, 
x Peripheral nerve injury 
x Arterial thrombus 
calcific debris, 
x Pseudoaneurysm 
x Arterio-venous fistula 
device) 
x Retroperitoneal bleeding 
x Bleeding from the puncture site 
x Hematoma 
x Deep vein thrombosis 
x Oozing from the puncture site 
x Infection 
x Vascular injury 
x Bruising at the puncture site 
x Inflammatory response 
x Vasovagal response 
x Death 
x Intimal tear / dissection 
x Vasospasm 
x Device failure/malfunction 
x Lower extremity ischemia 
x Wound dehiscence 
x Edema 
x Perforation of the vessel wall 
x Puncture site pain 
 
VASCADE 6/7F VCS was evaluated in a prospective, multi-center, randomized (2:1) clinical trial (the RESPECT Trial) in 
20 sites in the United States and one site in Australia, comparing VASCADE VCS to Manual Compression (MC).  The 
trial involved 420 patients undergoing diagnostic (n=211) or interventional (n=209) endovascular procedures.  Table 1, 
Table 2, and Table 3 summarize the reported major and minor complications in the trial for all patients, diagnostic 
patients, and interventional patients, respectively. 
 
Table1: Reported Major and Minor Complications - All Patients 
Access Site-Related Complications at 30 Days by Event 
Total 
(N=417) 
VASCADE 
(N=275) 
Manual 
Compression 
(N=142) 
p-value* 
Any access-site-related major complication 
0 
0.0% 
0 
0.0% 
1.00 
Access site-related bleeding requiring transfusion 
0 
0.0% 
0 
0.0% 
1.00 
Vascular injury requiring repair 
0 
0.0% 
0 
0.0% 
1.00 
New ipsilateral lower extremity ischemia causing a threat to the viability of 
the limb 
0 
0.0% 
0 
0.0% 
1.00 
Access site-related infection requiring intravenous antibiotics and/or 
extended hospitalization 
0 
0.0% 
0 
0.0% 
1.00 
New onset access site-related neuropathy in the ipsilateral lower extremity 
requiring surgical repair 
0 
0.0% 
0 
0.0% 
1.00 
Permanent access site-related nerve injury (> 30 days) 
0 
0.0% 
0 
0.0% 
1.00 
Any Access Site-Related Minor Complication 
3 
1.1% 
10 
7.0% 
0.002 
Access site-related bleeding requiring > 30 minutes to achieve hemostasis 
1 
0.4% 
10 
7.0% 
0.0001 
Access site-related hematoma > 6 cm 
1 
0.4% 
0 
0% 
1.00 
Late access site-related bleeding (following hospital discharge) 
0 
0% 
0 
0% 
1.00 
Ipsilateral lower extremity arterial emboli 
0 
0% 
0 
0% 
1.00 
Ipsilateral deep vein thrombosis** 
4 
1.5% 
0 
0% 
NA 
Access site-related vessel laceration 
0 
0% 
0 
0% 
1.00 
Access site wound dehiscence 
0 
0% 
0 
0% 
1.00 
Localized access site infection treated with intramuscular or oral antibiotics 
0 
0% 
0 
0% 
1.00 
Arteriovenous fistula not requiring treatment** 
1 
0.4% 
0 
0% 
NA 
Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection** 
1 
0.4% 
0 
0% 
NA 
Pseudoaneurysm not requiring treatment** 
4 
1.5% 
0 
0% 
NA 
New onset access site-related neuropathy in the ipsilateral lower extremity 
not requiring surgical repair 
1 
0.4% 
0 
0% 
1.00 
Ipsilateral pedal pulse diminished by two grades or transiently lost 
0 
0% 
0 
0% 
1.00 
*Two-sided Fisher's exact test 
 **Due to different complication-detecting methods between study arms (100 VASCADE patients and no other study patients underwent a 
femoral ultrasound exam in an ultrasound sub-study), rates for pseudoaneurysm requiring or not requiring treatment, arteriovenous fistula not 
requiring treatment, and ipsilateral deep vein thrombosis (which were detected by ultrasound exam) are presented but not compared between 
arms, nor are they included in the computation of the VASCADE overall minor complication rate (top row). 
  

Page 4 of 16 
Table2: Reported Major and Minor Complications Diagnostic Patients 
Access Site-Related Major Complications at 30 Days by 
Event 
Diagnostic 
(N=210) 
VASCADE 
(N=136) 
Manual 
Compression 
(N=74) 
p-value* 
Any access-site-related major complication 
0 
0.0% 
0 
0.0% 
1.00 
Access site-related bleeding requiring transfusion 
0 
0.0% 
0 
0.0% 
1.00 
Vascular injury requiring repair 
0 
0.0% 
0 
0.0% 
1.00 
New ipsilateral lower extremity ischemia causing a threat to the viability of 
the limb 
0 
0.0% 
0 
0.0% 
1.00 
Access site-related infection requiring intravenous antibiotics and/or 
extended hospitalization 
0 
0.0% 
0 
0.0% 
1.00 
New onset access site-related neuropathy in the ipsilateral lower extremity 
requiring surgical repair 
0 
0.0% 
0 
0.0% 
1.00 
Permanent access site-related nerve injury (> 30 days) 
0 
0.0% 
0 
0.0% 
1.00 
Any Access Site-Related Minor Complication 
2 
1.5% 
2 
2.7% 
0.61 
Access site-related bleeding requiring > 30 minutes to achieve hemostasis 
0 
0% 
2 
2.7% 
0.12 
Access site-related hematoma > 6 cm 
1 
0.7% 
0 
0% 
1.00 
Late access site-related bleeding (following hospital discharge) 
0 
0% 
0 
0% 
1.00 
Ipsilateral lower extremity arterial emboli 
0 
0% 
0 
0% 
1.00 
Ipsilateral deep vein thrombosis** 
3 
2.2% 
0 
0% 
NA 
Access site-related vessel laceration 
0 
0% 
0 
0% 
1.00 
Access site wound dehiscence 
0 
0% 
0 
0% 
1.00 
Localized access site infection treated with intramuscular or oral antibiotics 
0 
0% 
0 
0% 
1.00 
Arteriovenous fistula not requiring treatment** 
0 
0% 
0 
0% 
NA 
Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection** 
0 
0% 
0 
0% 
NA 
Pseudoaneurysm not requiring treatment** 
1 
0.7% 
0 
0% 
NA 
New onset access site-related neuropathy in the ipsilateral lower extremity 
not requiring surgical repair 
1 
0.7% 
0 
0% 
1.00 
Ipsilateral pedal pulse diminished by two grades or transiently lost 
0 
0% 
0 
0% 
1.00 
 
*Two-sided Fisher's exact test 
  
**Due to different complication-detecting methods between study arms (100 VASCADE patients and no other study patients underwent a femoral ultrasound 
exam in an ultrasound sub-study), rates for pseudoaneurysm requiring or not requiring treatment, arteriovenous fistula not requiring treatment, and ipsilateral 
deep vein thrombosis (which were detected by ultrasound exam) are presented but not compared between arms, nor are they included in the computation of  
the VASCADE overall minor complication rate (top row). 
 

Page 5 of 16 
Table3: Reported Major and Minor Complications 
Interventional Patients 
Access Site-Related Major Complications at 30 Days by Event 
Interventional 
(N=207) 
 
Manual 
 
VASCADE 
Compression 
p-value* 
(N=139) 
(N=68) 
Any access-site-related major complication 
0 
0.0% 
0 
0.0% 
1.00 
Access site-related bleeding requiring transfusion 
0 
0.0% 
0 
0.0% 
1.00 
Vascular injury requiring repair 
0 
0.0% 
0 
0.0% 
1.00 
New ipsilateral lower extremity ischemia causing a threat to the viability of 
the limb 
0 
0.0% 
0 
0.0% 
1.00 
Access site-related infection requiring intravenous antibiotics and/or 
extended hospitalization 
0 
0.0% 
0 
0.0% 
1.00 
New onset access site-related neuropathy in the ipsilateral lower extremity 
requiring surgical repair 
0 
0.0% 
0 
0.0% 
1.00 
Permanent access site-related nerve injury (> 30 days) 
0 
0.0% 
0 
0.0% 
1.00 
Any Access Site-Related Minor Complication 
1 
0.7% 
8 
11.8% 
0.001 
Access site-related bleeding requiring > 30 minutes to achieve hemostasis 
1 
0.7% 
8 
11.8% 
0.001 
Access site-related hematoma > 6 cm 
0 
0% 
0 
0% 
1.00 
Late access site-related bleeding (following hospital discharge) 
0 
0% 
0 
0% 
1.00 
Ipsilateral lower extremity arterial emboli 
0 
0% 
0 
0% 
1.00 
Ipsilateral deep vein thrombosis** 
1 
0.7% 
0 
0% 
NA 
Access site-related vessel laceration 
0 
0% 
0 
0% 
1.00 
Access site wound dehiscence 
0 
0% 
0 
0% 
1.00 
Localized access site infection treated with intramuscular or oral antibiotics 
0 
0% 
0 
0% 
1.00 
Arteriovenous fistula not requiring treatment** 
1 
0.7% 
0 
0% 
NA 
Pseudoaneurysm requiring thrombin injection or fibrin adhesive 
injection** 
1 
0.7% 
0 
0% 
NA 
Pseudoaneurysm not requiring treatment** 
3 
2.2% 
0 
0% 
NA 
New onset access site-related neuropathy in the ipsilateral lower extremity 
not requiring surgical repair 
0 
0% 
0 
0% 
1.00 
Ipsilateral pedal pulse diminished by two grades or transiently lost 
0 
0% 
0 
0% 
1.00 
 
*Two-sided Fisher's exact test 
  
**Due to different complication-detecting methods between study arms (100 VASCADE patients and no other study patients underwent a femoral ultrasound 
exam in an ultrasound sub-study), rates for pseudoaneurysm requiring or not requiring treatment, arteriovenous fistula not requiring treatment, and ipsilateral 
deep vein thrombosis (which were detected by ultrasound exam) are presented but not compared between arms, nor are they included in the computation of the 
VASCADE overall minor complication rate (top row). 
 

Page 6 of 16 
VASCADE 6/7F VCS Clinical Trial 
The RESPECT Study was a prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety 
and effectiveness of the study device in sealing common femoral arterial access sites and providing reduced times to 
hemostasis and ambulation compared with Manual Compression (MC) at the completion of diagnostic or interventional 
endovascular procedures (cardiac or peripheral vascular catheterizations) performed through 6F or 7F introducer sheaths.  
Patients were randomized in a 2:1 treatment device to control ratio.  The trial was conducted at 20 sites in the United 
States and one site in Australia. In an ultrasound sub-study, images of the access site were obtained from 100 
consecutively randomized, treated, VASCADE patients at 5 sites prior to hospital discharge. 
To be eligible for the trial, patients were required to be between 18 and 80 years of age; able and willing to sign an 
Informed Consent Form; acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular 
procedure via the common femoral artery using a 6F or 7F introducer sheath who were also acceptable candidates for 
post-procedure manual compression; and able and willing to complete a 30-day ± 7 days follow-up evaluation. Patients 
were excluded if they had clinically significant peripheral vascular disease; bleeding disorder; ipsilateral femoral 
arteriotomy within the previous 30 days; planned endovascular procedure within the next 30 days; previous vascular 
grafts at target access site; extreme morbid obesity (BMI greater than 45 kg/m2) or were underweight (BMI less than 20 
kg/m2); known allergy/adverse reaction to bovine derivatives; planned extended hospitalization; administration of low 
molecular weight heparin (LMWH) within 8 hours of the procedure; femoral artery diameter less than 6mm at access site; 
multi arterial sticks; received unfractionated heparin with an ACT greater than 300 seconds in the absence of a 
glycoprotein (GP) IIb/IIIa inhibitor or greater than 250 seconds in the presence of a glycoprotein IIb/IIIa inhibitor; intra-
procedural bleeding around sheath or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula; 
uncontrolled hypertension; or length of tissue tract estimated to be less than 2.5cm. 
A total of 420 patients, 211 diagnostic and 209 interventional patients, were enrolled. The mean age was 62 years and 
mean BMI was 30kg/m2. Twenty-nine percent (29%) of patients were female. The study also included 69 roll-in cases, 
consisting of 45 diagnostic and 24 interventional patients. The randomized VASCADE arm included 137 diagnostic and 
141 interventional patients, while the manual compression arm included 74 diagnostic and 68 interventional patients. 
Seventy-seven percent (77%) of the VASCADE interventional patients received bivalirudin, 27% received heparin, 60% 
received clopidogrel, and 8% received GP IIb/IIIa inhibitors. The mean Activated Clotting Time (ACT) in patients receiving 
unfractionated heparin for diagnostic patients was 221 seconds vs. 172 seconds in the VASCADE and manual 
compression groups, respectively. The mean ACTs in interventional patients were similar among groups, with the 
VASCADE group reporting 289.5 ± 136.9 seconds vs. 289.0 ± 100.7 seconds in the manual compression group. 
Enrolled patients were followed for 30±7 days. Four hundred fifteen (415) randomized patients (98.8%) completed 30-day 
follow-up. Three patients were prematurely randomized and immediately withdrawn from the study due to ineligibility; one 
was lost to follow-up and one withdrew consent to participate prior to 30-day follow-up. 
Effectiveness Results 
Table 4 summarizes the primary efficacy endpoint, Time to Hemostasis (TTH), and secondary efficacy endpoints, Time to 
Ambulation (TTA), Time to Discharge Eligibility (TTDE), and Time to Discharge (TTD). The primary efficacy endpoint, 
TTH, was defined as elapsed time between device removal, i.e., device removal for Cardiva VASCADE VCS and sheath 
removal for manual compression, and first observed and confirmed arterial hemostasis (no or minimal subcutaneous 
oozing and the absence of expanding or developing hematoma). TTA was defined as the elapsed time between device 
removal, i.e., device removal for Cardiva VASCADE VCS and sheath removal for manual compression, and  when 
ambulation was achieved (patient standing and walking at least 20 feet without re-bleeding). TTDE was defined as the 
elapsed time between device removal, i.e., device removal for Cardiva VASCADE VCS and sheath removal for manual 
compression, and when the patient was eligible for hospital discharge based upon an assessment of the access site. 
 
Table 4: Primary and Secondary Effectiveness 
  
  
  
  
  
Diagnostic 
(N=211) 
Interventional 
(N=209) 
Total 
(N=420) 
VASCADE 
(N=137) 
Manual 
Compression 
(N=74) 
p-value* 
VASCADE 
(N=141) 
Manual 
Compression 
(N=68) 
p-value* 
VASCADE 
(N=278) 
Manual 
Compression 
(N=142) 
p-value* 
Time to Hemostasis (minutes)  
N 
136 
74 
 
139 
68 
 
275 
142 
 
Mean 
4.0 
18.2 
< 0.0001 
5.5 
24.9 
< 0.0001 
4.8 
21.4 
< 0.0001 
Std Deviation 
4.2 
8.1 
 
6.3 
15.1 
 
5.4 
12.4 
 
Median 
2.6 
18.5 
< 0.0001 
3.3 
20.5 
< 0.0001 
3.0 
20.0 
< 0.0001 
Min 
0.6 
4.3 
 
0.8 
0.0 
 
0.6 
0.0 
 
Max 
24.7 
64.6 
 
31.6 
97.0 
 
31.6 
97.0 
 
Time to Ambulation (hours)  

Page 7 of 16 
  
  
  
  
  
Diagnostic 
(N=211) 
Interventional 
(N=209) 
Total 
(N=420) 
VASCADE 
(N=137) 
Manual 
Compression 
(N=74) 
p-value* 
VASCADE 
(N=141) 
Manual 
Compression 
(N=68) 
p-value* 
VASCADE 
(N=278) 
Manual 
Compression 
(N=142) 
p-value* 
N 
136 
74 
 
139 
68 
 
275 
142 
 
Mean 
2.6 
4.6 
< 0.0001 
5.0 
7.2 
0.003 
3.8 
5.8 
< 0.0001 
Std Deviation 
2.0 
1.6 
 
6.7 
3.7 
 
5.1 
3.1 
 
Median 
2.2 
4.4 
< 0.0001 
4.1 
6.4 
< 0.0001 
3.2 
5.2 
< 0.0001 
Min 
1.0 
1.7 
 
2.2 
2.5 
 
1.0 
1.7 
 
Max 
20.1 
11.0 
 
78.0 
22.8 
 
78.0 
22.8 
 
Time to Discharge Eligibility (hours) 
N 
136 
74 
 
138 
68 
 
274 
142 
 
Mean 
3.1 
5.0 
 
6.6 
8.2 
 
4.8 
6.5 
 
Std Deviation 
2.1 
1.6 
 
8.4 
4.0 
 
6.4 
3.3 
 
Median 
2.6 
4.8 
 
4.6 
7.0 
 
3.6 
5.7 
 
Min 
1.4 
2.2 
 
2.6 
3.0 
 
1.4 
2.2 
 
Max 
20.5 
11.3 
 
78.4 
23.2 
 
78.4 
23.2 
 
Time to Hospital Discharge (hours)  
N 
136 
74 
 
139 
68 
 
275 
142 
 
Mean 
12.0 
7.3 
 
24.5 
20.8 
 
18.3 
13.7 
 
Std Deviation 
45.4 
7.3 
 
16.2 
6.7 
 
34.5 
9.8 
 
Median 
3.4 
5.3 
 
23.4 
19.9 
 
17.2 
13.9 
 
Min 
1.7 
2.4 
 
3.4 
4.9 
 
1.7 
2.4 
 
Max 
432.9 
55.6 
 
147.6 
45.7 
 
432.9 
55.6 
 
*p-value from t-test for comparing means and Wilcoxon's test for comparing medians 
 
 
 
 
 
Table 5 summarizes the secondary effectiveness endpoint of Procedure Success. Procedure Success was defined as 
attainment of final hemostasis using any method and freedom from major vascular complications through 30 days. The 
Procedure Success Rate was 100% for VASCADE and Manual Compression. 
 
Table 5: Secondary Effectiveness, Procedure Success 
 
Procedure 
Treatment 
Assignment 
Number of 
Patients 
Number of 
Successes 
Success 
Rate 
95% Confidence 
Interval* 
Diagnostic  
VASCADE 
136 
136 
100% 
97% 
100% 
Manual Compression 
74 
74 
100% 
95% 
100% 
Interventional  
VASCADE 
139 
139 
100% 
97% 
100% 
Manual Compression 
68 
68 
100% 
95% 
100% 
Total  
Cardiva VCS 
275 
275 
100% 
99% 
100% 
Manual Compression 
142 
142 
100% 
97% 
100% 
*95% Exact Binomial Confidence Interval 
 
 
 
 
**Two-sided Fisher's exact test. 
 
 
 
 
 
 
Table 6 summarizes the results of Device Success. Device Success was defined as the ability to deploy the delivery 
system, deliver the collagen, and achieve hemostasis with the VASCADE Vascular Closure System alone or with 
adjunctive compression. The overall Device Success Rate for the total patients was 96%. 
 
Table 6: Secondary Effectiveness, Device Success 
Procedure 
Number of 
Patients** 
Number 
of 
Successes 
Success 
Rate 
95% Confidence 
Interval* 
Diagnostic 
136 
128 
94% 
88.7% 
97.4% 
Interventional 
139 
135 
97% 
92.8% 
99.2% 
*95% Exact Binomial Confidence Interval 
** Includes 6 instances of failure to follow written Instructions for Use. Excluding these 6 instances, Device success rates are 96% 
(Diagnostic), 99% (Interventional) and 98% (Total) 
 
Table 7, Table 8, Table 9, and Table 10 summarize the cumulative data for TTH, TTA, TTDE, and TTD, respectively. 
 
 

Page 8 of 16 
Table 7: Cumulative Time to Hemostasis (TTH) All Patients 
Time point 
Total 
(N=420) 
VASCADE 
(N=278) 
Manual 
Compression 
(N=142) 
N 
275 
142 
PLQXWH 
8 
3% 
1 
1% 
PLQXWHV 
51 
19% 
1 
1% 
PLQXWHV 
136 
49% 
1 
1% 
PLQXWHV 
195 
71% 
1 
1% 
PLQXWHV 
221 
80% 
5 
4% 
minutes 
246 
89% 
16 
11% 
PLQXWHV 
263 
96% 
85 
60% 
PLQXWHV 
274 
100% 
132 
93% 
 
Table 8: Cumulative Time to Ambulation (TTA) All Patients 
 
 
 
 
Time point 
Total 
(N=420) 
VASCADE 
(N=278) 
Manual 
Compression 
(N=142) 
N 
275 
142 
KRXU 
0 
0% 
0 
0% 
hours 
22 
8% 
1 
1% 
KRXUV 
122 
44% 
12 
8% 
KRXUV 
179 
65% 
31 
22% 
KRXUV 
255 
93% 
68 
48% 
KRXUV 
268 
97% 
131 
92% 
KRXUV 
270 
98% 
138 
97% 
 
Table 9: Cumulative Time to Discharge Eligibility (TTDE) All Patients 
 
 
 
 
Time point 
Total 
(N=420) 
VASCADE 
(N=278) 
Manual 
Compression 
(N=142) 
N 
274 
142 
KRXUV 
10 
4% 
0 
0% 
KRXUV 
152 
55% 
20 
14% 
KRXUV 
247 
90% 
79 
56% 
KRXUV 
257 
94% 
117 
82% 
KRXUV 
262 
96% 
131 
92% 
KRXUV 
270 
99% 
142 
100% 
KRXUV 
272 
99% 
142 
100% 
 
Table 10: Cumulative Time to Discharge (TTD) All Patients 
 
 
 
 
Time point 
Total 
(N=420) 
VASCADE 
(N=278) 
Manual 
Compression 
(N=142) 
N 
275 
142 
KRXUV 
1 
0% 
0 
0% 
KRXUV 
86 
31% 
12 
8% 
KRXUV 
123 
45% 
50 
35% 
KRXUV 
131 
48% 
66 
46% 
KRXUV 
134 
49% 
69 
49% 
KRXUV 
207 
75% 
129 
91% 
KRXUV 
265 
96% 
141 
99% 

Page 9 of 16 
Evaluation of VASCADE 5F VCS 
 
A. VASCADE 5F Confirmatory Trial 
The purpose of the VASCADE 5F study was to confirm the safety and effectiveness of the scaled-down 5F version of the 
VASCADE 6/7F VCS.  The 5F device is virtually identical to the slightly larger 6/7F VCS.  The study population was 
defined as patients undergoing cardiac or peripheral vascular catheterization procedures via the femoral artery approach 
when using a standard 5F introducer sheath.  The study was conducted at a single-center in Australia, and was a 
prospective, non-randomized, non-blinded, single treatment trial.  The inclusion and exclusion criteria were identical to the 
U.S. IDE RESPECT trial with the exception that patients had to be undergoing a catheterization procedure utilizing a 5F 
introducer sheath. 
 
Thirty (30) patients were enrolled into the study.  All of the patients enrolled in the study underwent diagnostic procedures.  
Patient demographic characteristics at baseline, such as gender, age, and BMI were comparable between the U.S. IDE 
trial and the 5F Australian confirmatory study.  The safety and effectiveness endpoints for the 5F confirmatory study were 
identical to the 6/7F study.  Identical to the pivotal RESPECT trial, the primary safety endpoint was the rate of combined 
major access site-related complications within 30 ± 7 days following the catheterization procedure.  The secondary safety 
endpoint was the rate of combined minor access site-related complications within 30 ± 7 days following the procedure.  
Identical to the IDE RESPECT trial, the primary effectiveness endpoint was TTH.  The secondary effectiveness endpoints 
were TTA, TTDE, TTD, procedure success, and device success. 
Results of 5F trial 
Table 1: Access Site-Related Major Complications 
Access Site-Related Major Complications 
5-French 
(N=30) 
Any access-site-related major complication 
1 
3.3% 
Access site re-bleeding requiring transfusion 
1* 
3.3% 
Vascular injury requiring repair 
0 
0.0% 
New ipsilateral lower extremity ischemia causing a threat to 
the viability of the limb 
0 
0.0% 
Access site-related infection requiring intravenous 
antibiotics and/or extended hospitalization 
0 
0.0% 
New onset access site-related neuropathy in the ipsilateral 
lower extremity requiring surgical repair 
0 
0.0% 
Permanent access site-related nerve injury (> 30 days) 
0 
0.0% 
One occurrence only. 
 
Table 2: Access Site-Related Minor Complications 
Access Site-Related Minor Complications 
5-French 
(N=30) 
Any Access Site-Related Minor Complication 
1 
3.3% 
Access site-related bleeding requiring > 30 minutes to achieve hemostasis 
0 
0.0% 
Access site-related hematoma > 6 cm 
0 
0.0% 
Late access site-related bleeding (following hospital discharge) 
0 
0.0% 
Ipsilateral lower extremity arterial emboli 
0 
0.0% 
Ipsilateral deep vein thrombosis 
0 
0.0% 
Access site-related vessel laceration 
0 
0.0% 
Access site wound dehiscence 
0 
0.0% 
Localized access site infection treated with intramuscular or oral antibiotics 
0 
0.0% 
Arteriovenous fistula not requiring treatment 
0 
0.0% 
Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection 
0 
0.0% 
Pseudoaneurysm not requiring treatment 
0 
0.0% 
New onset access site-related neuropathy in the ipsilateral lower extremity 
not requiring surgical repair 
1* 
3.3% 
Ipsilateral pedal pulse diminished by two grades or transiently lost 
0 
0.0% 
*One occurrence only. 
 
 
 

Page 10 of 16 
Table 3: TTH, TTA, TTDE, and TTD Effectiveness Endpoints 
  
5 French 
  
(N=30) 
Time to Hemostasis 
(minutes) 
  
N 
30 
Mean 
3.0 
Std Deviation 
2.4 
Median 
2.3 
Min 
0.2 
Max 
11.8 
Time to Ambulation (hours) 
. 
N 
30 
Mean 
4.1 
Std Deviation 
5.9 
Median 
2.3 
Min 
1.5 
Max 
25.9 
Time to Discharge 
Eligibility (hours) 
. 
N 
30 
Mean 
5.6 
Std Deviation 
9.0 
Median 
3.1 
Min 
2.0 
Max 
46.9 
Time to Hospital Discharge 
(hours) 
. 
N 
30 
Mean 
11.9 
Std Deviation 
16.0 
Median 
3.5 
Min 
2.0 
Max 
73.0 
 
 
B. VASCADE 5F Engineering Analysis 
 
Engineering analysis for the scaled down VASCADE 5F VCS included Collagen Patch size calculations resulting in a 
proportionally smaller Collagen Patch as compared with the VASCADE 6/7F VCS device. These analyses confirmed 
equivalent tissue-tract space-filling capability between the 5F and 6/7F versions of the VASCADE device. In addition, 
fundamentally the same verification and validation testing was completed for the 5F VASCADE VCS device as was 
completed for the 6/7F VASCADE VCS device. 
 
Conclusions 
The results from the RESPECT clinical trial demonstrate that patients who have undergone diagnostic or interventional 
cardiac or peripheral vascular endovascular procedures using a 6F or 7F introducer sheath and were treated with 
VASCADE VCS have statistically and clinically significant decreased times to hemostasis and ambulation for diagnostic 
and interventional procedures, and statistically and clinically significant decreased time to discharge eligibility for 
diagnostic procedures, when compared to patients treated with manual compression. In addition, the trial demonstrated 
that patients treated with the VASCADE VCS were noninferior to patients treated with manual compression with respect to 
major access site-related complications. 
 
A confirmatory clinical study and engineering analysis demonstrated that the VASCADE 5F VCS is equivalent to the 
VASCADE 6/7F VCS in design and performance. 
 
 
 

Page 11 of 16 
DEVICE PREPARATION AND PROCEDURE 
 
At the time of initial introducer sheath placement, patient body habitus should be evaluated to provide reasonable 
assurance that the distance between the femoral arteriotomy and the skin surface is greater than 2.5cm.  After 
introducer sheath placement, an anterior oblique fluoroscopic image may be digitally recorded and stored, so that the 
arteriotomy site location can be compared to the position of the radiopaque marker just prior to Collagen Patch release. 
The radiopaque marker is located immediately distal to the Collagen Patch.  A single wall, common femoral 
arteriotomy should also be confirmed at this time. 
 
CAUTION: During access care should be taken so that the tissue tract is not pushed laterally or medially prior to accessing the 
vessel. This is to avoid misalignment of the tissue tract and the Collagen Patch relative to the arteriotomy site once the device is 
removed from the vessel which may result in prolonged time to hemostasis. 
 
1. Use the Cardiva VASCADE VCS only as described below: 
Device 
Model 
Sheath Size 
Sheath 
Length 
Disc Size 
Collagen 
Patch Length 
Device Working 
Length 
Maximum OD 
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2. Inspect the package for damage (breaks, tears, open seals, water damage, etc.) and verify that expiration 
date has not passed. 
 
3. Using standard sterile technique, remove the tray containing the VASCADE VCS Catheter and Clip from the 
foil pouch.  Carefully remove VASCADE VCS Catheter and Clip from the tray.  Examine the device by first 
verifying that the Black Sleeve is locked in position and the Collagen Patch is not exposed.  Also verify that the 
Yellow-Blue Key (Figure 2) is not engaged in the Lock (the Lock is located at the proximal aspect of the Black 
Sleeve), and the Yellow-Blue Key is located at the proximal end of the Catheter Shaft.  Inspect the Catheter 
further by examining the deployed VASCADE Disc.  To deploy the Disc, hold the Silver Handle firmly and pull 
back on the Black Actuator until it locks in place.  When the Disc is locked in the deployed position, the Green 
Segment will become visible as shown in Figure 3.  Examine the Disc, which should appear circular and 
symmetrical with an intact membrane.  Figure 4 shows the deployed and collapsed Disc.  After examination, 
collapse the Disc by pressing the Black Actuator tip down (Figure 5).  The tip of the VASCADE VCS Catheter 
should return to its original profile. 
 
 
 
 
 
 
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4. Verify that the sheath is not positioned in a tortuous vessel.  If required, retract the sheath slightly to a non-
tortuous location.  Verify that the sheath is still positioned within the artery. 
 
WARNING:  Verify there is no vessel tortuosity or side branches within 3-4 cm from the distal opening of the sheath and the 
end of the sheath is not resting against the vessel wall.  This is to prevent any vascular injury as a result of advancing the 
catheter.  If required, retract the sheath slightly to a non-tortuous location, being careful not to lose vessel access. 
 
5. Flush the sheath with sterile saline solution prior to insertion of the device. 
6. Prior to insertion of device in the introducer sheath, momentarily insert the tip of the VCS Catheter in saline 
solution up to the White Marker Stripe and quickly remove. 
 
CAUTION: Do not soak the VASCADE VCS Catheter in saline. Momentarily insert only the Catheter tip in saline solution 
immediately before use to avoid over-hydration of the patch, which may result in Catheter pull through during the sleeve 
retraction step. 
 

Page 12 of 16 
7. Gently insert the VASCADE VCS Catheter (with disc collapsed) into the introducer sheath hub as shown in 
Figure 6. Insert the VASCADE VCS Catheter such that approximately half of the Lock is visible.  Make certain 
that the Lock is NOT fully inserted into the sheath.  See Figure 7 for correct placement. 
 
CAUTION: Do not advance VASCADE VCS Catheter into the patient if resistance is felt due to risk of vascular damage. 
 
 
 
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8. Deploy the Disc by holding the Silver Handle and pulling back the Black Actuator until it locks in place as shown 
in Figure 8. 
 
CAUTION: Do not continue to pull on the Black Actuator once it is locked in place as this may damage the device. 
 
NOTE: When the Disc is properly deployed, the Green Segment will become visible distal to the Black Actuator.  If 
the catheter is not properly locked in place, the Black Actuator will slide back to its original position and the Green 
Segment will disappear (in VASCADE 5F approximately 1mm of the Green Segment remains visible when disc is 
collapsed) indicating that the Disc is not properly deployed.  In this case repeat the step for deploying the Disc by pulling 
the Black Actuator more firmly until it locks in place. 
 
9. Gently remove sheath, without applying any compression at the access site or holding the VASCADE VCS 
Catheter, as shown in Figure 9.  As the sheath slides over the VASCADE VCS Catheter, grasp the Catheter 
proximal to the LOCK as it exits the distal end of the introducer sheath.  Continue sliding the sheath over the 
VASCADE VCS Catheter and discard sheath. 
 
CAUTION: Compressing the access site during sheath removal may not allow the Disc to track back to the arteriotomy and may cause 
Disc deformation. This may lead to inability to achieve temporary hemostasis. 
 
10. Apply gentle tension on the Black Actuator until temporary hemostasis is achieved.  Note whether any portion of 
the White Marker Stripe, which is located near the distal aspect of the Black Sleeve, is visible above the skin.  If it 
is, then the length of the tissue tract is less than 2.5 cm, indicating the tissue tract may not be long enough for the 
Collagen Patch. 
 
WARNING:  If any portion of the White Marker Stripe is showing DO NOT RELEASE the Collagen Patch as this may increase the 
risk of infection. 
 
NOTE:  If any portion of the White Marker Stripe is showing and the collagen patch is not to be deployed continue 
the procedure as follows: 
For diagnostic cases: the VASCADE VCS Catheter should be removed by collapsing the Disc and then manual 
compression can be applied per institutional protocol. 
For anti-coagulated patients: the Clip may be applied to the VASCADE VCS Catheter on the skin surface 
as shown in Figure 10 to maintain temporary hemostasis.  The device may then stay in dwelling to allow time for 
the ACT level to normalize.  The device can then be removed followed by application of manual compression 
per institutional protocol to achieve final hemostasis. 
 

Page 13 of 16 
11. Once temporary hemostasis is achieved, apply the Clip to the Black Sleeve at skin level as shown in Figure 10.  
Utilize fluoroscopy to verify that the deployed Disc is positioned against the intimal surface of the 
arteriotomy by noting the position of the more proximal radiopaque marker.  The marker should be at the 
arteriotomy site which can be verified by comparing its location with the location of the arteriotomy documented 
at the time of the introducer sheath insertion.  The Collagen Patch is immediately proximal to this Marker Band.  
The Distal Marker Band locates the distal end of the Disc. 
 
CAUTION: Applying too much upward tension on the Black Actuator may cause disc to pull out of vessel.  Should this occur, 
convert to your LQVWLWXWLRQ¶VPDQXDOFRPSUHVVLRQSURWRFRO 
WARNING: It is important to ensure that the Disc is in contact with the intimal aspect of the arteriotomy before deploying the 
extra- vascular Collagen Patch to avoid releasing the Collagen Patch in the vessel.  This step requires fluoroscopy (Figure 11). 
 
 
 
 
 
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EXTRA-VASCULAR COLLAGEN PATCH DEPLOYMENT AND DEVICE REMOVAL 
12. Once the Disc location is verified, expose the extra-vascular resorbable Collagen Patch by unlocking the 
Black Sleeve.  This is done by grasping the Lock with the left hand, between the thumb and the index finger, 
and grasping the Yellow-Blue Key with the right hand and then sliding the Yellow-Blue Key into the Lock until 
no blue color is visible, as shown in Figure 12.  Once the Sleeve is unlocked and while still holding on to the 
Lock, remove the Clip with the right hand, and gently slide the Lock back along the angle of entry to retract 
the Black Sleeve as shown in Figure 13.  The Black Sleeve will move freely after some initial resistance.  A 
second resistance point may be felt after the sleeve is moved approximately 1.6 cm (0.6 inch). 
Proceed to fully retract the Black Sleeve proximally to the Silver Handle.  This action exposes the Collagen 
Patch extra-vascularly, which will swell at the arteriotomy site.  The Collagen Patch may be allowed to swell 
for up to 30 seconds prior to removal of the VASCADE VCS Catheter.  The Clip should be reapplied during 
the Collagen Patch swell period with minimal tension on the Catheter (Figure 14). 
 
NOTE: If the Black Sleeve does not retract easily, recheck that the blue end of the Yellow-Blue Key is fully engaged 
in the Lock. 
 
NOTE: If the Collagen Patch is removed during sleeve retraction, for non-anti-coagulated patients, collapse the Disc, 
remove the Catheter and apply manual compression, per institutional protocol.  If the patient is anti -coagulated, the 
Clip may be applied to the VASCADE VCS Catheter on the skin surface to maintain temporary hemostasis.  The 
device may then stay in dwelling in order to allow time for the ACT level to normalize.  The device can then be 
removed followed by application of manual compression to achieve final hemostasis. 
 
 
 
 
 
 
 
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Page 14 of 16 
13. After patch swell time (≤ 30 seconds) has elapsed, remove the Clip.  Rest the palm of the hand on the patient 
and grasp the green tube between the thumb and the index finger as shown in Figure 15.  With slack in the 
catheter, collapse the Disc by pressing on the Black Actuator Tip as shown in Figure 16.  When the Disc is fully 
collapsed, the Green Segment should not be visible for 6/7F device, or only a small portion, approximately 1mm, 
may be visible for the 5F device.  While keeping the green tube stationary pull back the VASCADE VCS 
Catheter proximally.  The Catheter Handle will move approximately 1.5cm while the green portion of the 
catheter remains stationary.  This action slides the collapsed catheter Disc by the Collagen Patch while 
maintaining the position of the Collagen Patch.  Once this initial movement has occurred, let go of the Green 
Tube.  Gentle manual compression may be applied at the arteriotomy site.  Remove the VASCADE VCS 
Catheter, and apply manual compression. 
Alternative Technique: AFTER 15-30 seconds of patch swell time and PRIOR TO collapsing the Disk, remove 
the Clip. Rest the palm of the hand on the patient and grasp the green tube between the thumb and the index 
finger as shown in Figure 15. Push the green tube in the proximal direction approximately 1.5 cm while gently 
pulling back on the VASCADE VCS Catheter to maintain Disk position against artery wall.  The green tube may 
be slid back and forth 2-3 times in order to assure release of the Collagen patch from device.  Upon completion of 
this step, apply proximal compression, collapse the Disc by pressing on the Black Actuator Tip as shown in 
Figure 16. Gentle manual compression may be applied at the arteriotomy site.  Remove the VASCADE VCS 
Catheter, and apply manual compression. 
 
14. Observe for arterial hemostasis.  Manual compression can be used to decrease or stop any tract ooze until full 
hemostasis is achieved. 
NOTE:  Prior to the VASCADE VCS Catheter removal confirm that the Disc is completely collapsed by verifying 
that the Green Segment is no longer visible for 6/7F device and only a small portion approximately 1mm is 
visible for the 5F device.  Care should be taken not to compress directly over the catheter during the removal step 
of the device so that the catheter can be easily removed and without displacement of Collagen Patch.  Note: The 
implanted Collagen Patch should not be affected by Magnetic Resonance Imaging (MRI). 
 
15. Apply sterile dressing to site per institution protocol. Maintain bed rest and periodically check site until patient is 
ready to ambulate. 
16. Complete information on Patient Implant Card and provide to the patient. 
 
 

Page 15 of 16 
 
GRAPHICAL SYMBOLS ON THE VASCADE VCS PACKAGING 
 
Do not reuse 
 
Store at room 
temperature 
Manufacturer 
 
Sterilized using 
irradiation 
 
Latex Free 
 
Authorized 
representative 
in the European 
Community 
Use by 
 
Lot Number 
 
Keep Dry 
 
Caution, see 
Instructions for 
Use 
 
Model Number 
 
Do not use if 
the product 
sterilization 
barrier or its 
packaging is 
compromised 
Quantity of 
systems in 
package 
 
Federal (USA) 
law restricts this 
device to sale 
by or on order 
of a physician 
Rx Only 
 

Page 16 of 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Design for what’s humanly possible 
 
 
 
 
 
 
Cardiva Medical, Inc. 
2900 Lakeside Drive, Suite # 160 
 Santa Clara, CA 95054 
USA 
Tel:  +1 408-470-7170 
US Toll Free Tel: 1-866-602-6099 
US Toll Free Fax: 1-866-602-1795 
 
www.cardivamedical.com 
 
Authorized Representative: 
MedPass International Ltd. 
Bretforton, Evensham, Worcestershire., 
 WR11 7JJ,United Kingdom 
Tel/Fax: +44 (0) 14 52 619 222 
medpass.ar@medpass.org  
 
 
 
LIMITED WARRANTY 
Cardiva Medical, Inc. warrants that each VASCADE Vascular Closure System is free from defects in workmanship and material under normal use and 
service, and provided it is used prior to the stated expiration date.  Cardiva Medical, Inc. will not be liable for any incidental, special or consequential 
loss, damage or expense direct or indirect from the use of its product.  Liability under this warranty is limited to refund or replacement of any device 
that has been found by Cardiva Medical, Inc. to be defective at the time of shipment.   Damage to the device through misuse, alteration, improper 
storage or improper handling shall void this limited warranty.  The remedies set forth in this warranty and limitation shall be the exclusive remedy 
available to any person.  No employee, agent or distributor of Cardiva Medical, Inc. has any authority to alter or amend this limited warranty, or 
assume or bind Cardiva Medical, Inc. to any additional liability or responsibility with respect to this device. There is no express or implied warranty, 
including any implied warranty of merchantability or fitness for a particular purpose, on the Cardiva Medical, Inc. product(s) described herein.