Clinical Investigation Plan (CIP) for: Safety and Performance Study for Arterial Large Hole Vascular Closure Device - ELITE Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Large Hole Percutaneous Arterial Closure
- Sponsor
- Vivasure Medical Limited
- Enrollment
- 120
- Primary Endpoint
- Primary Effectiveness Endpoint - Time to Haemostasis
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed Description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal Elite. The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 14 to 22 F sheaths, via the common femoral artery will be screened against the inclusion/exclusion criteria. All subjects shall have a pre-discharge, 30-Days ± 7-Days and 180-Days ± 30-Days follow-up assessment. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
Investigators
Eligibility Criteria
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
- •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 (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,
- •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,
- •Known existing nerve damage in the target leg,
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint - Time to Haemostasis
Time Frame: 20 Minutes
Time to Haemostasis (TTH) defined as elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery-device) removal to first observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma.
Primary Safety Endpoint - Major access site complications
Time Frame: through 30 Days
Rate of major access site complications attributable to the PerQseal Elite device
Secondary Outcomes
- Secondary Effectiveness Endpoint - Time to Ambulation(through 24 hours)
- Secondary Safety Endpoint - Incidence of Minor Access Site Complications(Through 30 Days)
- Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate(through 30 days)
- Secondary Effectiveness Endpoint - Time to Device Deployment(20 Minutes)
- Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate(10 Minutes)
- Secondary Effectiveness Endpoint - Total Closure Time(40 Minutes)