The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® in 75 patients in approximately 10 European investigational sites. The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 12 to 20 F sheaths, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number. All subjects shall have an immediately post procedure, \~24 hour, 1 and 3 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee on a continuous basis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Large hole closure system
Kerckhoff Klinik, Bad Nauheim
Bad Nauheim, Hesse, Germany
CardioVasculäres Centrum
Frankfurt am Main, Hesse, Germany
Uniklinik Köln, Herzzentrum
Cologne, North Rhine-Westphalia, Germany
Major Vascular Complications [Safety]
Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2)
Time frame: up to 1 month post implantation
Minor Vascular Complications [Safety]
Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2)
Time frame: up to 1 month from implantation
Study Device Technical Success Rate [Performance]
Percentage of closures (Limbs) with Technical Success, for the PerQseal® closure device, not requiring alternative therapy to achieve haemostasis
Time frame: within 24 hours
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