Clinical Study of the Medeon Biodesign XPro™

NCT ID: NCT03171155

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2019-09-12

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.

Conditions

Percutaneous Closure of Arteriotomy in Common Femoral Artery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XPro System

Implantation of XPro System during percutaneous vascular closure

Group Type: EXPERIMENTAL

XPro System

Intervention Type: DEVICE

Implantation of the XPro System

Interventions

XPro System

Implantation of the XPro System

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medeon Biodesign, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal North Shore Hospital

St Leonards, New South Wales, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Auckland City Hospital

Auckland, , New Zealand

Christchurch Hosptial

Christchurch, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

China Medical University Hospital

Taichung, , Taiwan

Countries

Australia; New Zealand; Taiwan

Other Identifiers

CIP-LHC03

Identifier Type: -

Identifier Source: org_study_id