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

  • STATUS
    Recruiting
  • days left to enroll
    17
  • participants needed
    1062
  • sponsor
    Xiongjing Jiang
Updated on 28 April 2022
peripheral vascular disease

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).

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).

Details
Condition Peripheral Vascular Diseases, Percutaneous Intervention Via Femoral Artery
Treatment Perclose ProGlide, Angio-seal VIP
Clinical Study IdentifierNCT05334095
SponsorXiongjing Jiang
Last Modified on28 April 2022

Eligibility

Yes No Not Sure

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 procedure via femoral arterial access
Patients' arterial puncture site is in the common femoral artery confirmed by a femoral angiogram, and ≥10mm away from the ostium of the inferior epigastric artery (IEA) and the bifurcation of superficial femoral artery and the profunda femoris artery

Exclusion Criteria

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