PerQseal® Clinical Study (NCT05653336) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PerQseal® Clinical Study
United States149 participantsStarted 2023-03-30
Plain-language summary
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 participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 19 years,
✓. Clinically indicated for a percutaneous arterial interventional catheter-based procedure, e.g., transcatheter aortic valve replacement/implantation (TAVR/TAVI) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aortic aneurysm repair (TEVAR), or use of a circulatory assist device or extracorporeal oxygenation using a common femoral arteriotomy created by a 12 to 22 F sheath (arteriotomy up to 26 F),
✓. 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,
✕. Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/µl or subjects on long term anticoagulants with an INR \> 2 within 12 hours prior to index procedure,
✕. Significant anaemia (haemoglobin \< 9 g/dL or haematocrit \< 27%), within 24 hours prior to index procedure,
✕. Known type II heparin-induced thrombocytopenia,
✕. Documented left ventricular ejection fraction \< 20%,
✕. Ipsilateral or contralateral lower extremity amputation.
What they're measuring
1
Primary Safety Endpoint - Major Access Site Complications
Timeframe: through 30 days
2
Primary Effectiveness Endpoint - Time to Hemostasis
. Claudication (Rutherford category 3 or greater), documented untreated iliac or common femoral artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of target leg,
✕. Known existing nerve damage in the target leg,