PerQseal® Device for Percutaneous Vascular Closure
(PATCH Trial)
Recruiting in Palo Alto (17 mi)
+17 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Vivasure Medical Limited
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on long-term anticoagulants with an INR > 2 within 12 hours prior to the procedure, you may be excluded from the trial. It's best to discuss your specific medications with the trial team.
What data supports the idea that PerQseal® Device for Percutaneous Vascular Closure is an effective treatment?
The available research does not provide specific data on the effectiveness of the PerQseal® Device for Percutaneous Vascular Closure. Instead, it discusses complications and outcomes related to other vascular closure devices like Angio-Seal and Perclose. These studies highlight issues such as arterial blockages and the need for surgical intervention, suggesting that while these devices can be effective, they also carry risks. Without direct data on PerQseal®, it's difficult to compare its effectiveness to other treatments.
12345What safety data exists for the PerQseal® Device for vascular closure?
The provided research does not contain specific safety data for the PerQseal® Device or its variants. The studies mentioned focus on other vascular closure devices like Solysafe, StarClose SE, and Perclose ProGlide™, discussing their safety and complications. To find safety data for the PerQseal® Device, one would need to look for studies or reports specifically evaluating this device.
678910Eligibility Criteria
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.Inclusion Criteria
I am 19 years old or older.
Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements
I am not pregnant or breastfeeding and do not plan to become pregnant during the study.
+1 more
Exclusion Criteria
Known type II heparin-induced thrombocytopenia
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.
+19 more
Participant Groups
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).
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.
PerQseal® Closure Device System is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as PerQseal Closure Device System for:
- Percutaneous sealing of a common femoral arteriotomy in patients following interventional therapeutic endovascular procedures
🇺🇸 Approved in United States as PerQseal Closure Device System for:
- Haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing percutaneous catheter-based interventional procedures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ScrippsLa Jolla, CA
Montefiore Medical Center (multiple centers)Bronx, NY
The Cleveland ClinicCleveland, OH
University of BuffaloBuffalo, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Vivasure Medical LimitedLead Sponsor
References
Arterial thrombosis after using Angio-Seal. [2016]Percutaneous closure systems of arterial puncture sites are being used more and more in modern endovascular practice. In this article, we report five cases of thrombotic complications following Angio-Seal deployment which required to be treated in our department between June 2004 and January 2006. We carried out a computerized literature review using "vascular closure" as a keyword and elected 106 articles published between 1992 and 2007. The analysis of this literature review showed that the rate of percutaneous closure complications was similar to the rate of manual compression complications, which is still the reference method. The complications associated with the use of these systems were more complex and more often required surgical repair. The severity and frequency of these complications differ based on the type of closure systems. The vascular surgeon in charge must have a good knowledge of these systems and of the complications each of them entails to be able to treat them in the most appropriate way.
Treatment of Angio-Seal® Vascular Closure Device-Induced Acute Femoral Artery Occlusion with SilverHawk® Directional Atherectomy. [2020]Vascular closure devices provide a safe and cost-effective method to achieve rapid hemostasis and early ambulation after angiographic procedures. Rarely, they can result in arterial injury with resultant stenosis or acute arterial closure requiring open surgical intervention. We report an Angio-Seal® vascular closure device-induced acute arterial closure successfully treated percutaneously with the SilverHawk® plaque excision system. This report discusses the possible mechanisms of Angio-Seal® induced arterial occlusion and various percutaneous options for treatment.
Angiographic follow-up after suture-mediated femoral artery closure. [2019]Percutaneous closure devices are used in as many as 30% of all endovascular studies. Despite widespread use of these devices, only limited imaging has been performed after percutaneous closure. In this study, arteriograms of patients who had undergone suture-mediated closure with the Perclose device were reviewed.
Suture knot embolism--a rare complication of percutaneous arterial closure device. [2010]Percutaneous closure devices used after percutaneous endovascular procedures have become more popular over the past decade. Occlusive vascular complication of the device is rare but always leads to limb-threatening consequence. We report a case of arterial occlusion caused by distal embolization of the suture material in the percutaneous closure device.
Mynx Vascular Closure Device in Arterial Endovascular Procedures. [2022]Vascular closure devices have been used to achieve hemostasis of percutaneous access sites following endovascular procedures, with reported decreased time for arterial control as well as decreased time to ambulation. We sought to determine rates and risk factors of postoperative bleeding complications and failures using these devices from a single institution experienced in the use of vascular closure devices.
Late cardiac perforation following percutaneous atrial septal defect closure using the Solysafe device. [2012]Percutaneous atrial septal defect closure has been demonstrated to be a safe and effective procedure. Many different devices have been utilized during the last decade with a low complication rate. We report a patient who presented with cardiac tamponade 6 months after ASD closure using the Solysafe device. Emergency surgery demonstrated a disarticulated device as well as a broken wire migrated into the pericardial space causing cardiac perforation and tamponade. To the best of our knowledge, this is the first report of late cardiac perforation following ASD closure using the Solysafe device.
Registry-Based Prospective, Active Surveillance of Medical-Device Safety. [2022]The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).
Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database. [2013]To evaluate the type and frequency of complications associated with the StarClose SE vascular closure device reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for comparison with complications reported in clinical trials.
Perclose Proglide™ for vascular closure. [2021]In the past 20 years, numerous percutaneous vascular closure devices have been tested and compared with manual compression and to surgical cut-down. The suture-mediated closure device Perclose ProGlide™ system (Abbott Vascular, CA, USA) emerged as a safe and effective alternative for many procedures requiring either small or large bore vascular accesses. In this review, we will discuss the characteristics of this vascular closure device and the main studies that proved its potential to reduce vascular complications, time to deambulation, time to discharge and patient discomfort.
Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia? [2019]Mechanical closure devices for arterial hemostasis after angiography, such as the Perclose suture-mediated closure system, are designed to decrease time to ambulation and improve patient comfort. Although these devices are safe and efficacious, to date there has been little reported about use of the Perclose device in a cohort consisting exclusively of patients with lower extremity peripheral vascular disease. The purpose of this study was to determine the safety and efficacy of routine use of the Perclose system in patients with documented peripheral vascular disease undergoing angiography to treat chronic lower extremity ischemia.
Endovascular retrieval of a dislodged femoral arterial closure device with Alligator forceps. [2016]The Angio-Seal (St. Jude Medical, Minnetonka, Minn) is a frequently used percutaneous femoral artery closure device to obtain hemostasis after arterial catheterization. Separation and migration of the device, leading to distal embolization and limb-threatening ischemia necessitating emergency surgery, is reported but extremely rare. We present a unique case of successful endovascular bailout management of a dislocated Angio-Seal with use of an Alligator Tooth Retrieval forceps (Cook Medical, London, United Kingdom).
Arterial puncture closure using a collagen plug, II. (VasoSeal). [2004]Various vascular closure devices have come into common usage by most angio/interventional radiologists and cardiologists over the past 6 or 7 years. This has occurred despite the "real angiographers hold their own punctures" mindset that many of us learned in training. In our practice, we tried a number of different devices, but began using VasoSeal as our primary closure method in mid-1998. Since then, we have performed approximately 2400 procedures in which the VasoSeal device was deployed. The purpose of this article is to review the technique of VaseSeal closure of percutaneous arteriotomy sites.