Clinical Study of the Medeon Biodesign XPro™

MedeonBio

Status

Completed

Conditions

Percutaneous Closure of Arteriotomy in Common Femoral Artery

Treatments

Device: XPro System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03171155

CIP-LHC03

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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