Safety and Performance Study for Arterial Large Hole Vascular Closure Device (NCT05951634) | Clinical Trial Compass
UnknownNot Applicable
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
120 participantsStarted 2023-08
Plain-language summary
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 14 to 22 F sheaths.
Note, for reference purposes, it is expected arteriotomies created with 14 to 22 F sheaths will create an arteriotomy in the range of 16 - 26 F (being the outer diameter of these sheaths).
Who can participate
Age range19 Years
SexALL
See this in plain English?
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 14 to 22F sheath (arteriotomy up to 26F).
✓. 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 (example: 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 Haemostasis
. Previous groin surgery within the region of the ipsilateral access,
✕. 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,