Clinical trial NCT05334095: Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
Official title: Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease: a Prospective Single-center Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Vascular Diseases
Percutaneous Intervention Via Femoral Artery
Keywords: Peripheral Vascular Diseases
closure device
Femoral Artery
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 1062
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).

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 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.

Primary outcomes:
measure: Incidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required
timeFrame: 30 days post procedure
measure: Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)
timeFrame: 180 days post procedure
measure: Deployment procedure time
timeFrame: within 24 hours of device deployment
measure: Time to haemostasis from removing the sheath until haemostasis
timeFrame: within 24 hours of device deployment
measure: Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)
timeFrame: within 5 minutes of device deployment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease
name: Xiongjing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: