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Vascular Closure Device

PerQseal® Device for Percutaneous Vascular Closure

N/A
Recruiting
Led By William Gray, Dr.
Research Sponsored by Vivasure Medical Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device called PerQseal, which helps close up the hole in the artery after certain heart procedures. It is aimed at patients who need a reliable way to stop bleeding after these procedures. The device works like a plug to seal the hole and prevent bleeding.

Who is the study for?
This trial is for adults over 19 who need a catheter-based procedure like TAVR/TAVI, EVAR, TEVAR, or use of assist devices through the femoral artery. Women must not be pregnant or planning pregnancy during the study. Participants must consent to follow-up visits.
What is being tested?
The PerQseal vascular closure device system is being tested for its ability to safely and effectively close large openings in the femoral artery after procedures that require big sheaths (12-22 F size).
What are the potential side effects?
While specific side effects are not listed here, potential risks may include bleeding, infection at the puncture site, discomfort or pain due to device application.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint - Time to Hemostasis
Primary Safety Endpoint - Major Access Site Complications
Secondary study objectives
Secondary Effectiveness Endpoint - PerQseal Technical Success Rate
Secondary Effectiveness Endpoint - PerQseal Treatment Success Rate
Secondary Effectiveness Endpoint - Time to Ambulation
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects implanted with PerQseal Vascular Closure DeviceExperimental Treatment1 Intervention
Subjects implanted with bioabsorbable implant to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Percutaneous vascular closure devices, such as the PerQseal system, Perclose, and Angio-Seal, are designed to achieve hemostasis at the arteriotomy site following catheter-based interventions. The PerQseal system uses a bioabsorbable implant to seal the arteriotomy, promoting natural vessel healing. Perclose employs sutures to close the puncture site, while Angio-Seal uses a collagen plug to achieve hemostasis. These mechanisms are crucial for patients as they reduce bleeding complications, promote faster recovery, and minimize the need for prolonged manual compression, thereby improving overall procedural safety and patient comfort.
Secondary Femoral Access Hemostasis During Transcatheter Aortic Valve Replacement: Impact of Vascular Closure Devices.Endovenous management of saphenous vein reflux. Endovenous Reflux Management Study Group.

Find a Location

Who is running the clinical trial?

Vivasure Medical LimitedLead Sponsor
10 Previous Clinical Trials
548 Total Patients Enrolled
William Gray, Dr.Principal InvestigatorLankenau heart Institute
Sean Lyden, Dr.Principal InvestigatorThe Cleveland Clinic

Media Library

PerQseal® Closure Device System (Vascular Closure Device) Clinical Trial Eligibility Overview. Trial Name: NCT05653336 — N/A
Percutaneous Vascular Closure Research Study Groups: Subjects implanted with PerQseal Vascular Closure Device
Percutaneous Vascular Closure Clinical Trial 2023: PerQseal® Closure Device System Highlights & Side Effects. Trial Name: NCT05653336 — N/A
PerQseal® Closure Device System (Vascular Closure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653336 — N/A
~48 spots leftby Oct 2025