Status:
UNKNOWN
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
Lead Sponsor:
Xiongjing Jiang
Conditions:
Peripheral Vascular Diseases
Percutaneous Intervention Via Femoral Artery
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 f...
Detailed 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
1062 Patients enrolled
Trial Details
Trial ID
NCT05334095
Start Date
August 20 2019
End Date
September 1 2022
Last Update
April 19 2022
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037