A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal® Closure Device System When Used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Percutaneous Large Hole Vascular Closure
- Sponsor
- Vivasure Medical Limited
- Enrollment
- 149
- Locations
- 18
- Primary Endpoint
- Primary Effectiveness Endpoint - Time to Hemostasis
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
The objective of this pivotal study 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, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal closure system to support a pre-market approval submission.
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 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.
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),
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint - Time to Hemostasis
Time Frame: 20 Minutes
Elapsed time in minutes from PerQseal (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 device
Secondary Outcomes
- Secondary Effectiveness Endpoint - PerQseal Technical Success Rate(10 Minutes)
- Secondary Effectiveness Endpoint - Time to Ambulation(through 24 hours)
- Secondary Safety Endpoint - Minor Access Site Complications(through 30 Days)
- Secondary Effectiveness Endpoint - PerQseal Treatment Success Rate(through 30 days)
- Secondary Effectiveness Endpoint - Time to Device Deployment(20 Minutes)
- Secondary Effectiveness Endpoint - Total Closure Time(40 Minutes)