Clinical Study of the Medeon Biodesign XPro™

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System

Conditions
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Percutaneous Closure of Arteriotomy in Common Femoral Artery

Intervention / Treatment
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* Device: XPro System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: Implantation of the XPro System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XPro System<br>Implantation of XPro System during percutaneous vascular closure | Device: XPro System<br>* Implantation of the XPro System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures. | 15 minutes | 
| Freedom from major VARC-2 events | Freedom from major VARC-2 events within 30 days of the procedure. | Up to 30 days of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from minor VARC-2 events | Freedom from minor VARC-2 events up to 30 days of the procedure. | Up to 30 days of procedure | 
| Successful hemostasis with the XPro System | Without the need for any access-site-related adjunctive surgical or endovascular procedures and freedom from major VARC-2 events. | at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure | 
| Freedom from access-site infection | Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization. | Up to 30 days of procedure |