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

Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease: a Prospective Single-center Randomized Non-inferiority Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Peripheral Vascular Diseases; Percutaneous Intervention Via Femoral Artery
• Intervention / Treatment: Device: Perclose ProGlide; Device: Angio-seal VIP

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).

• Study Type: Interventional
• Enrollment (Anticipated): 1062
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perclose ProGlide; Perclose ProGlide 6F Suture-Mediated Closure (SMC) System	Device: Perclose ProGlide; After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
Placebo Comparator: Angio-seal VIP; Angio-seal VIP Vascular Closure Device	Device: Angio-seal VIP; After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Vascular injury related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection.; 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.; haemorrhage related to access site requiring transfusion, or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15%; Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics.; Nerve injury related to access site which is permanent or requires surgery.	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required	Minor ipsilateral access site vascular complications included: Access site pseudoaneurysm or AV fistula documented by ultrasound, neither surgical nor percutaneous intervention is required.; Post-discharge access site-related haemorrhage requiring ≥ 30 minutes manual compression to re-achieve hemostasis.; Lower extremity arterial stenosis attributed to arterial access or closure, whereas neither surgical nor percutaneous intervention is required.; haemorrhage related to access site with no transfusion required. while, transfusion is required when haemoglobin decreased by <5g/dl or hematocrit (HCT) decreased by <15%.; Access site hematoma ≥ 6 cm, neither blood transfusion nor surgical intervention is required.; Localized access site infection treated with intramuscular or oral antibiotics.; Transient access site-related nerve injury.	30 days post procedure
Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)	Major vascular complications include: Vascular injuries related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection.; New onset lower extremity ischemia that is attributed to arterial access or closure, and the ABI of the ipsilateral limb of access site decreased by ≥0.15 or requiring surgical or additional percutaneous intervention.; Bleeding related to access site requiring transfusion or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15%; Infection requiring a extended hospitalization for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics.; Nerve injury related to access site is permanent or requires surgery.	180 days post procedure
Deployment procedure time	Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time)	within 24 hours of device deployment
Time to haemostasis from removing the sheath until haemostasis	Haemostasis is considered as insignificant bleeding on the bandage or small continuous oozing, manual compression is no longer needed or less than 5 minutes.	within 24 hours of device deployment
Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)	0 cm means no pain, while 10 cm means the worst imaginable pain or the worst pain one had experienced	within 5 minutes of device deployment

Collaborators and Investigators

• Sponsor: Xiongjing Jiang

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Peripheral Vascular Diseases; Femoral Artery; closure device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2019-ZX09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes