Clinical trial NCT03171155: Clinical Study of the Medeon Biodesign XPro™
Official title: Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Closure of Arteriotomy in Common Femoral Artery
Lead sponsor: Medeon Biodesign, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Implantation of the XPro System
Primary purpose: TREATMENT

Brief summary: To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.

Detailed description: This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure.

Eligibility criteria: Inclusion Criteria:

* Patient is \> 18 years old
* Patient is scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR involving access through the femoral artery using an 8-18 Fr introducer sheath
* Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
* Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
* Patient is willing and able to complete follow-up

Exclusion Criteria:

* Prior intra-aortic balloon pump at access site
* Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%
* Common femoral artery lumen diameter is \< 6 mm
* Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
* Prior vascular surgery, vascular graft, or stent in region of access site
* Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
* Patients with significant anemia ((Hgb \< 10 g/dL, Hct \< 30%)
* Patient with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
* Patients with renal insufficiency (serum creatinine level \> 221µmol/L) or renal transplant
* Known allergy to contrast reagent
* Inability to tolerate aspirin and/or other anticoagulation treatment
* Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 350 seconds for more than 24 hours after the procedure
* Connective tissue disease (e.g., Marfan's Syndrome)
* Thrombolytics (e.g. t-PA, streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
* Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
* Patients who are morbidly obese BMI \> 40 kg/m2
* Planned major intervention or surgery within 30 days following the interventional procedure
* Patients who are unable to ambulate at baseline
* Currently participating in a clinical study of an investigational device or drug that has not completed study endpoint
* Known allergy to any device component
* Patient is known or suspected to be pregnant or lactating
* Life expectancy \< 1 year as judged by the investigator
* Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating Intra-Procedure
* Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
* Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
* Ipsilateral femoral venous sheath during the catheterization procedure
* Common femoral artery calcium, which is fluoroscopically visible
* Patients where there is difficulty inserting the introducer sheath or greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
* Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
* Evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site
* Patients with intra-procedural bleeding around access site
* Evidence of active systemic or local groin infection
* Patients receiving glycoprotein IIb/IIIa inhibitors during, or after the catheterization procedure

Primary outcomes:
measure: Time to Hemostasis
timeFrame: 15 minutes
measure: Freedom from major VARC-2 events
timeFrame: Up to 30 days of procedure
Secondary outcomes:
measure: Freedom from minor VARC-2 events
timeFrame: Up to 30 days of procedure
measure: Successful hemostasis with the XPro System
timeFrame: at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
measure: Freedom from access-site infection
timeFrame: Up to 30 days of procedure
Other outcomes:
measure: Time to ambulation
timeFrame: Up to 48 hours
measure: Time to hospital discharge
timeFrame: Up to 2 weeks
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hosptial
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: