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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
Study Summary
This trial tests a device used to stop bleeding from artery punctures during interventional procedures.
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.Check my eligibility
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).See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint - Time to Hemostasis
Primary Safety Endpoint - Major Access Site Complications
Secondary outcome measures
Secondary Effectiveness Endpoint - PerQseal Technical Success Rate
Secondary Effectiveness Endpoint - PerQseal Treatment Success Rate
Secondary Effectiveness Endpoint - Time to Ambulation
+3 moreTrial 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.
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a minor procedure on my leg with a small tool and stitches or pressure for bleeding control within the last month.I have a bleeding disorder or my blood doesn't clot properly.My femoral artery is suitable for a specific closure device after a scan.I am 19 years old or older.I do not have any ongoing infections, including skin or groin infections.My kidney function is very low or I am on dialysis.I am scheduled for another leg procedure within 30 days after the first one.Surgery is not an option for my leg's condition.I am not pregnant or breastfeeding and do not plan to become pregnant during the study.I have nerve damage in my leg.I currently have COVID-19, tested positive recently, or was exposed to someone with it in the last two weeks.I had a minor procedure on my leg with a small tool and a dissolvable device to stop bleeding within the last 3 months.My leg arteries are very twisted, as shown by a CT scan.I have had a leg amputation.I had a procedure on my leg with a large tube more than 3 months ago.I have severe leg pain when walking due to a major artery in my leg being narrowed or previously treated.I need a heart or blood vessel procedure using a catheter.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects implanted with PerQseal Vascular Closure Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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