Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease

Last updated: April 18, 2022
Sponsor: Xiongjing Jiang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Peripheral Arterial Occlusive Disease

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT05334095
2019-ZX09
  • Ages 18-85
  • All Genders

Study Summary

This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is ≥18 and < 85 years of age.
  • Patient is willing to provide written informed consent prior to study device use.
  • Patient is undergoing a peripheral vascular diagnostic and/or interventional procedurevia femoral arterial access.
  • Patients' arterial puncture site is in the common femoral artery confirmed by afemoral angiogram, and ≥10mm away from the ostium of the inferior epigastric artery (IEA) and the bifurcation of superficial femoral artery and the profunda femorisartery.

Exclusion

Exclusion Criteria:

  • The femoral access site has been punctured within 30 days, or deployed with acollagen-based hemostasis device within 90 days, or a suture-mediated closure device.
  • Patients having a hematoma, pseudoaneurysm or arteriovenous fistula present prior tosheath removal confirmed by a femoral angiogram.
  • Patients with minimum femoral artery calcium which is fluoroscopically visible ataccess site or femoral artery diameter stenosis greater than 50%.
  • Ankle-brachial index (ABI) of the ipsilateral limb of access site cannot be measureddue to severe peripheral artery disease (PAD).
  • Patients who are pregnant or lactating.

Study Design

Total Participants: 1062
Study Start date:
August 20, 2019
Estimated Completion Date:
September 01, 2022

Study Description

Prospective, single-center, randomized (1:1), open-label, non-inferiority study in 1062 patients comparing Perclose ProGlide (test device) to the Angio-seal VIP (standard comparator).

Connect with a study center

  • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing 100037
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.