What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for percutaneous vascular closure, such as the PerQseal vascular closure device system, typically include devices like collagen plugs, suture-mediated systems, and sealants. Known side effects of these treatments can include local complications such as bleeding, hematoma, infection at the puncture site, and arterial occlusion. Other potential side effects may involve allergic reactions to the materials used in the closure device, pseudoaneurysm formation, and, in rare cases, device failure leading to prolonged bleeding or the need for surgical intervention.

What prior FDA approvals exist?

The FDA has approved several vascular closure devices for achieving haemostasis at the arteriotomy site following percutaneous procedures. Notable examples include the Angio-Seal, Perclose ProGlide, and StarClose SE. These devices are designed to reduce bleeding complications and facilitate quicker patient recovery by sealing the puncture site in the artery. The PerQseal vascular closure device system, currently under study, aims to achieve similar outcomes by providing effective haemostasis for larger arteriotomies created by 12 to 22 F sheaths.

What other types of research exist?

Promising novel alternatives to the PerQseal vascular closure device system for percutaneous vascular closure patients include the MANTA Vascular Closure Device and the InClosure VCD. The MANTA device is designed for large-bore arteriotomies and has shown favorable outcomes in achieving rapid hemostasis with a low complication rate. The InClosure VCD is another emerging option that offers a suture-mediated closure mechanism, providing secure and reliable closure for various sheath sizes.

← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 minutes

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.

Do I qualify?Apply below to find out

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.