arteriotomy artery puncture
Conditions
Interventions
The name of the product being investigated is the PerQseal® Elite Closure Device. PerQseal® Elite Closure Device will be used in conjunction with the 18F PerQseal® Elite Introducer. The PerQseal Elite
Sponsors
Vivasure Medical Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 19 years, 2. 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 22 F sheath (arteriotomy up to 26 F), 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.
Exclusion criteria
Exclusion criteria: Baseline Exclusion Criteria: 1. Evidence of current systemic bacterial or cutaneous infection, including groin infection, 2. Known bleeding diathesis, definite or potential coagulopathy, platelet count lower than 100,000/µl or subjects on long term anticoagulants with an INR higher than 2 within 12 hours prior to index procedure, 3. Significant anaemia (example: haemoglobin lower than 9 g/dL or haematocrit lower than 27%), within 24 hours prior to index procedure, 4. Known type II heparin-induced thrombocytopenia, 5. Documented left ventricular ejection fraction lower than 20%, 6. Ipsilateral or contralateral lower extremity amputation, 7. Previous groin surgery within the region of the ipsilateral access, 8. Claudication (Rutherford category 3 or greater), documented untreated iliac or common femoral artery diameter stenosis greater than 50% or previous bypass surgery/stent placement in the common femoral artery of target leg, 9. Known existing nerve damage in the target leg, 10.Renal insufficiency (Glomerular Filtration Rate = 30 ml/min or baseline serum creatinine higher than 2.5 mg/dl) or on renal replacement therapy, 11. Known allergy to any of the materials used in the PerQseal Elite device (refer to Investigator’s Brochure), 12. Subject is unsuitable for surgical repair of the target leg access site, 13. Subject has undergone a percutaneous procedure greater than 8F sheath in the target leg, within the 90-days prior to index procedure, 14. Subject has undergone a percutaneous procedure of 8F sheath or less using an absorbable intravascular closure device for haemostasis, in the target leg, within the 90-days prior to index procedure, 15. Subject has undergone a percutaneous procedure of 8F 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, 16. Evidence of marked tortuosity of the femoral or external iliac arteries in the target leg, based on pre-primary procedure CT angiography, 17. Evidence of arterial diameter stenosis greater than 20% within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography, 18. 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, 19. Target femoral artery diameter is less than 7 mm, based on pre-primary procedure CT angiography, 20. Further planned endovascular/catheter-based procedure in the target leg in the 30- days following the index procedure, 21. Subject is enrolled in another investigational medical device or drug study, 22. Subject has been previously enrolled in this clinical study, 23. Current COVID-19 infection (with or without symptoms), recent positive test for COVID- 19 within two weeks, or recent exposure to a person with COVID-19 infection within two weeks. Procedural Exclusion Criteria*: 24. Initial common femoral arterial access achieved with manual palpation or blind arterial stick access, without use of an image guided approach (ultrasound or angiography), 25. Difficult dilation during initial target femoral artery access (e.g., that damages or kinks dilators) while st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: The primary safety endpoint is the rate of major access site complications attributable to the PerQseal Elite device through 30-days, as adjudicated by an independent Clinical Events Committee (CEC). The endpoint is a composite comprised of the following elements: 1. Access site-related bleeding due to a failure of the PerQseal Elite device that requires transfusion of blood product(s), or 2. Device-related vascular injury that requires surgical repair or percutaneous stent-graft placement, or 3. Any new and sustained (longer than 24 hrs) device-related ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram, which causes a threat to the viability of the limb, and/or requires surgical repair or additional percutaneous intervention, or 4. Surgery for device-related nerve injury, or 5. Permanent (lasting to 30-days) device-related nerve injury, or 6. Access site infection requiring intravenous antibiotics, drainage and/or extended hospitalisation. Primary Effectiveness Endpoint: The Primary effectiveness endpoint is the elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery Device) removal from the patient to first observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of minor vascular access site complications attributable to the PerQseal Elite Closure Device through 30-days from implantation (inclusive), (as per definitions). Effectiveness: assessed by technical success rate for the PerQseal Elite Closure Device at discharge or within 5 days of implantation, is non-inferior to a Technical Success Performance Goal derived from a recent focused literature review in an equivalent patient population of the technical success rates associated with alternative large hole closure devices. Other parameters that will be reported are: PerQseal Elite Treatment Success Rate, Time to Device Deployment, Total Closure Time, Time to Ambulation, Incidence of Major Access Site Complications per VARC-3 and Incidence of Minor Access Site Complications per VARC-3. | — |
Countries
Denmark, Germany, Ireland, Netherlands
Contacts
Public ContactC Martin
Vivasure Medical Ltd.
Outcome results
None listed