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

Xiongjing Jiang

Status: Unknown

Conditions: Peripheral Vascular Diseases; Percutaneous Intervention Via Femoral Artery

Treatments: Device: Perclose ProGlide; Device: Angio-seal VIP

Study type: Interventional

Funder types: Other

Identifiers

NCT05334095

2019-ZX09

Details and patient eligibility

About

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).

Full 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).

Enrollment: 1,062 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,062 participants in 2 patient groups, including a placebo group

Perclose ProGlide

Active Comparator group

Description:

Perclose ProGlide 6F Suture-Mediated Closure (SMC) System

Treatment:

Device: Perclose ProGlide

Angio-seal VIP

Placebo Comparator group

Description:

Angio-seal VIP Vascular Closure Device

Treatment:

Device: Angio-seal VIP