Condition: Large Hole Percutaneous Venous Closure · Sponsor: Vivasure Medical Limited
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to support a CE-mark and a PMA submission.
This description comes directly from the study's public registry record.
Chris Martin · +353 91 395 442 · Chris.Martin@vsuremed.com
Always discuss trial participation with your own doctor first.
| Erasmus UMC | Rotterdam, Rotterdam, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06007339