PerQseal®+ Early Feasibility Study

Completed · Not applicable

Conditions studied: Percutaneous Large Hole Vascular Closure

In brief

The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.

Key facts

Study ID

NCT05163548

Run by

Vivasure Medical Limited

People needed

15

Starts

2022-03-08

Expected to finish

2022-07-07

Last updated by the study team

2023-04-26

Who can join

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

You may qualify if…

• Age ≥ 19 years, 2. Clinically indicated for a large bore interventional transcatheter procedure, e.g., transcatheter aortic valve repair (TAVR) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) using a percutaneous common femoral arteriotomy created by a 14 to 22 F sheath, 3. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements, 4. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

You may not qualify if…

• Baseline Exclusion Criteria 1. Evidence of systemic bacterial or cutaneous infection, including groin infection Baseline Exclusion Criteria
• Evidence of 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 anemia (hemoglobin < 9 g/dL or hematocrit < 27%), within 24 hours prior to index procedure,
• Known type II heparin-induced thrombocytopenia,
• NYHA functional class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit, within 24 hours prior to primary procedure,
• Documented left ventricular ejection fraction < 20%,
• Unilateral or bilateral lower extremity amputation.
• Claudication (e.g., 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 use of an intra-aortic balloon pump through the target leg access site within 90 days prior to the index procedure,
• Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable intravascular closure device for hemostasis, in the target vessel, 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 hemostasis in the target leg, within the 30 days prior to index procedure,
• Evidence of marked tortuosity of the femoral or external iliac artery 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 7 mm in diameter, based on pre-primary procedure CT angiography,
• Further planned endovascular procedure in the target leg in the 30 days following the index procedure,
• Subject is enrolled in another investigational medical device or drug study
• Subject has been previously enrolled in this clinical study.
• Current COVID-19 infection (with or without symptoms), recent positive test for COVID-19, or recent exposure (within two weeks) to a person with COVID-19 infection.

Where it is running

• The Valley Hospital — Ridgewood, New Jersey, United States
• Weill Cornell Medicine — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Montefiore Hospital — The Bronx, New York, United States
• Lankenau Heart Institute — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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