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

NCT05334095 | Unknown DMC FDA Device

• 1 other identifier: 2019-ZX09
• Study Type: interventional
• Target: 1,062
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Vascular Diseases; Percutaneous Intervention Via Femoral Artery

Keywords

Peripheral Vascular Diseases; closure device; Femoral Artery

Outcome Measures

Primary Outcomes (1)

• Incidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days

  Deployment procedure success is defined as haemostasis after the delivery and release of a closure device, manual compression is no longer needed or less than 5 minutes, and no more closure devices are needed. Major vascular complications include: 1. Vascular injury related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection. 2. New onset lower extremity ischemia attributed to arterial access or closure, and/or the ABI of the ipsilateral limb of access site decreased by ≥0.15 or requiring surgical or additional percutaneous intervention. 3. haemorrhage related to access site requiring transfusion, or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15% 4. Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics. 5. Nerve injury related to access site which is permanent or requires surgery.

  30 days post procedure

Secondary Outcomes (5)

• Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required

  30 days post procedure

• Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)

  180 days post procedure

• Deployment procedure time

  within 24 hours of device deployment

• Time to haemostasis from removing the sheath until haemostasis

  within 24 hours of device deployment

• Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)

  within 5 minutes of device deployment

Study Arms (2)

Perclose ProGlide

ACTIVE COMPARATOR

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

Device: Perclose ProGlide

Angio-seal VIP

PLACEBO COMPARATOR

Angio-seal VIP Vascular Closure Device

Device: Angio-seal VIP

Interventions

Perclose ProGlide DEVICE

After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.

Perclose ProGlide

Angio-seal VIP DEVICE

After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP

Angio-seal VIP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiongjing Jiang: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiongjing Jiang, MD

  Fuwai Hospital, National Center for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiongjing Jiang, MD

CONTACT

+861088322385; jxj103@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 19, 2022
• Study Start: August 20, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CN (1)