PerQseal® Clinical Study (NCT05653336)
A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal® Closure Device System When Used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures
🩺 Plain-English Summary (8th-Grade Level)
The objective is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve 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.
Who can join: Review the eligibility criteria below.
Location: HonorHealth — Scottsdale, Arizona
Age range: 19 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- HonorHealth — Scottsdale, Arizona
- Scripps — La Jolla, California
- Northern Light Eastern Maine Medical Center — Bangor, Maine
- Cooper University Hospital — Camden, New Jersey
- The Valley Hospital — Paramus, New Jersey
- University of Buffalo — Buffalo, New York
- Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Stony Brook University Hospital — Stony Brook, New York
- Montefiore Medical Center (multiple centers) — The Bronx, New York
- The Cleveland Clinic — Cleveland, Ohio
- UPMC Pinnacle Health — Mechanicsburg, Pennsylvania
- UPenn - Perelman Center for Advanced Medicine, — Philadelphia, Pennsylvania
- Lankenau Institute for Medical Research — Wynnewood, Pennsylvania
- The Texas Heart Institute — Houston, Texas
- St Franziskus Hospital — Münster, North Rhine-Westphalia
- Leipzig University Hospital — Leipzig, Saxony
- St. Gertrauden Krankenhaus (SGK) — Berlin,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Percutaneous Large Hole Vascular Closure clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.