Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
NCT ID: NCT05334095
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1062 participants
INTERVENTIONAL
2019-08-20
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Perclose ProGlide
Perclose ProGlide 6F Suture-Mediated Closure (SMC) System
Perclose ProGlide
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
Angio-seal VIP
Angio-seal VIP Vascular Closure Device
Angio-seal VIP
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP
Interventions
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Perclose ProGlide
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
Angio-seal VIP
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Xiongjing Jiang
OTHER
Responsible Party
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Xiongjing Jiang
Professor
Principal Investigators
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Xiongjing Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital, National Center for Cardiovascular Disease
Locations
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Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-ZX09
Identifier Type: -
Identifier Source: org_study_id
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