IRB Study Number 23-547
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The Vivasure Medical PerQseal Closure Device System is indicated for the percutaneous delivery of a 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. This closure device will be used for EVARs, TAVRs, and TEVARs.
Inclusion Criteria
- Age ≥ 19 years.
- Clinically indicated for a percutaneous arterial interventional catheter-based procedure, TAVR, TEVAR, EVAR with use of a 12-22 F sheath.
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
Exclusion Criteria
- Evidence of current systemic bacterial or cutaneous infection, including groin infection.
- Ipsilateral or contralateral lower extremity amputation.
- Known existing nerve damage in the target leg.
- Subject is unsuitable for surgical repair of the target leg assess site.
- Known allergy to any of the materials used in the PerQseal device.
- Significant anaemia within 24 hours prior to index procedure.
