PerQseal® Clinical Study

Running, not enrolling · Not applicable

Conditions studied: Percutaneous Large Hole Vascular Closure

In brief

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.

Key facts

Study ID

NCT05653336

Run by

Vivasure Medical Limited

People needed

149

Starts

2023-03-30

Expected to finish

2025-06-01

Last updated by the study team

2025-01-28

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Baseline 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.
• 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,
• Renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or baseline serum creatinine > 2.5 mg/dL) or on renal replacement therapy,
• Known allergy to any of the materials used in the PerQseal device (refer to Instructions for Use),
• Subject unsuitable for surgical repair of the target leg access site,
• Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90-days prior to index procedure,
• Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable intravascular closure device for haemostasis, in the target leg, within the 90-days prior to index procedure,
• Subject has undergone a percutaneous procedure of 8 F sheath or less using a suture mediated closure device or manual/mechanical pressure for haemostasis in the target leg, within the 30-days prior to index procedure,
• Evidence of marked tortuosity of the femoral or external iliac arteries in the target leg, based on pre-primary procedure CT angiography,
• Evidence of arterial diameter stenosis > 30% within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography,
• Evidence of anterior wall calcification of the target common femoral artery (other than small, diffuse deposits which in the opinion of the investigator will not impede the vascular closure procedure) within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography,
• Target femoral artery diameter is less than 6 mm or 7 mm, depending on whether S (small) or L (large) PerQseal Introducer will be used for arteriotomy closure, respectively, based on pre-primary procedure CT angiography,
• Further planned endovascular/catheter-based procedure in the target leg in the 30-days following the index procedure.
• Subject is enrolled in another investigational medical device or drug study,

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• Scripps — La Jolla, California, United States
• Northern Light Eastern Maine Medical Center — Bangor, Maine, United States
• Cooper University Hospital — Camden, New Jersey, United States
• The Valley Hospital — Paramus, New Jersey, United States
• University of Buffalo — Buffalo, New York, United States
• Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Montefiore Medical Center (multiple centers) — The Bronx, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• UPMC Pinnacle Health — Mechanicsburg, Pennsylvania, United States
• UPenn - Perelman Center for Advanced Medicine, — Philadelphia, Pennsylvania, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• The Texas Heart Institute — Houston, Texas, United States
• St Franziskus Hospital — Münster, North Rhine-Westphalia, Germany
• Leipzig University Hospital — Leipzig, Saxony, Germany
• St. Gertrauden Krankenhaus (SGK) — Berlin, Germany

Full record on ClinicalTrials.gov

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