RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)

Study Overview
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Brief Summary
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The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.

Detailed Description
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A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing femoral arterial access sites and providing reduced times to hemostasis and ambulation compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control ratio.

Official Title
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A Multi-Center, Prospective, Randomized, Controlled, Trial to Evaluate the Safety and Efficacy of the Cardiva VASCADE VCS vs. Manual Compression for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures

Conditions
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Surgical Wound

Intervention / Treatment
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* Other: Manual compression
* Device: Cardiva VASCADE™ Vascular Closure System


Participation Criteria
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Eligibility Criteria
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Pre-Operative Inclusion Criteria: Patients undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath Pre-Operative Exclusion Criteria: Advanced refusal of blood transfusion, if necessary; Active systemic or a cutaneous infection or inflammation; Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease 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); Severe co-existing morbidities having a life expectancy of less than 30 days; Currently involved in any other investigational clinical trial; Ipsilateral femoral arteriotomy within the previous 30 days; Planned endovascular procedure within the next 30 days; Previous ipsilateral femoral artery closure using a permanent implant-based closure device; Previous vascular grafts or surgery at the target vessel access site; History of symptomatic peripheral arterial disease, revascularization or deep vein thrombosis in the ipsilateral limb; Unilateral or bilateral lower extremity amputation(s); Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; Renal insufficiency (serum creatinine of > 2.5 mg/dl); Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); Unable to routinely walk at least 20 feet without assistance (see protocol); Known allergy/adverse reaction to bovine derivatives, sodium hyaluronate or hyaluronan preparations; Procedures that extend hospitalization (e.g., staged endovascular procedure, CABG); Administration of low molecular weight heparin (LMWH) within 8 hours of the procedure. Intra-op Exclusion Criteria An introducer sheath with an overall length greater than 11 cm, or not 6 Fr or 7 Fr diameter; Femoral artery diameter less than 6 mm at access site; Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, back wall stick, etc.); Angiographic evidence of more than minimal calcium, atherosclerotic disease, or stent within 1 cm of the puncture site; Overlapping Common Femoral Vein and Femoral Artery at access site; Placement of ipsilateral venous sheath during procedure; Arterial access site located not at common femoral artery (e.g., on or below the bifurcation, above the lower border of the inferior epigastric artery, or above the pelvic brim); More than one access site required; Loss of distal pulses in the ipsilateral extremity during the procedure; Subjects receiving unfractionated heparin with an ACT greater than 300 seconds in the absence of a glycoprotein IIb/IIIa inhibitor or greater than 250 seconds in the presence of a glycoprotein IIb/IIIa inhibitor (may wait to remove introducer sheath until ACT level reaches the target value); Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula; Systemic hypertension (BP greater than 180/110 mmHg) or hypotension (BP less than 90/60 mmHg) prior to randomization; Length of the tissue tract, the distance between the anterior arterial wall and skin, is estimated to be less than 2.5 cm; If the physician deems that a different method should be used to achieve hemostasis of the arterial site or that the subject should not attempt ambulation according to the protocol requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual compression<br>Using manual compression to reach hemostasis | Other: Manual compression<br>* Standard of Care<br>|
| Experimental: VASCADE™ Vascular Closure System<br>The Cardiva VASCADETM Vascular Closure System (VCS) is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 6 Fr or 7 Fr procedural sheaths. | Device: Cardiva VASCADE™ Vascular Closure System<br>* Investigational Hemostatic Vascular Closure System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis (TTH) | Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis. | Up to 1 hour | 
| Rate of Combined Access Site-related Major Complications | Primary safety endpoint Access site-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. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; Permanent access site-related nerve injury. (> 30 days) | 30 days +/- 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation (TTA) | Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding | Up to 1 day | 
| Time to Discharge Eligibility (TTDE) | Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team | Up to 2 days | 
| Time to Hospital Discharge (TTHD) | Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital | Up to 2 days | 
| Device Success | Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression | Up to 1 day | 
| Procedure Success | Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days | 30 days +/- 7 days | 
| Rate of Combined Minor Access Site Complications | Secondary safety endpoint Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis; Access site-related hematoma > 6 cm; Late access site-related bleeding (following hospital discharge); Ipsilateral lower extremity arterial emboli; Ipsilateral deep vein thrombosis; Access site-related vessel laceration; Access site wound dehiscence; Localized access site infection treated with intramuscular or oral antibiotics; Arteriovenous fistula not requiring treatment; Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; Pseudoaneurysm not requiring treatment; New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair; Ipsilateral pedal pulse diminished by two grades or transiently lost. | 30 days +/- 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular closure system, manual compression, femoral arteriotomy, percutaneous endovascular procedures