Large Hole Percutaneous Venous Closure
Conditions
Keywords
Venous Closure, Percutaneous closure, Large bore closure
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients 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 Elite closure system to support a CE-mark and a PMA submission.
Detailed description
This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite in up to 97 patients at up to 12 European investigational sites. The study shall not be blinded prior to, during or post the procedure. Patients undergoing a percutaneous catheter-based venous interventional procedure (e.g., mitral valve repair, leadless pacemaker implantation, circulatory assist or ECMO via large bore femoral vein catheter) requiring a venotomy created by 14 to 22F sheaths (venotomies up to 26F), via the common femoral vein will be screened against the study inclusion/exclusion criteria. All subjects shall have a 30-minute, 60-minute, pre-discharge (\ 48 hours), 30-Days ± 7-Days and 180-Days ± 30-Days follow-up assessments. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
Interventions
DEVICEPerQseal ELITE
The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: PerQseal Elite VCD or PerQseal Elite closure device and/or PerQseal Elite Introducer.
Sponsors
Vivasure Medical Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 19 years. 2. Clinically indicated for a percutaneous venous interventional catheter-based procedure, e.g., mitral valve edge to edge repair, left atrial appendage device closure, leadless pacemaker implantation, patent foramen ovale closure or use of a circulatory assist device or extracorporeal oxygenation using a common femoral venotomy created by a 14 to 22F sheath (venotomy up to 26F). 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. Baseline
Exclusion criteria
1. Evidence of current systemic bacterial or cutaneous infection, including groin infection, 2. Known bleeding diathesis, unstable INR, definite or potential coagulopathy, platelet count \< 100,000/μl or subjects on long term anticoagulants with an INR \> 2.2 within 12 hours prior to index procedure, 3. Significant anaemia (example: haemoglobin \< 8 g/dL or haematocrit \< 22%), within 24 hours prior to index procedure, 4. Known type II heparin-induced thrombocytopenia, 5. Documented right ventricular dysfunction \< 13%, 6. Ipsilateral or contralateral lower extremity amputation, 7. Previous groin surgery within the region of the ipsilateral vessel access, 8. Common femoral vein diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral vein of target leg, 9. Known existing nerve damage in the target leg, 10. Nephrotic syndrome or renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or baseline serum creatinine \> 2.5 mg/dl) or on renal replacement therapy or albumin level \< 3.5 g/dl or symptoms of pitting oedema, 11. Systolic pulmonary artery pressure \> 60 mmHg 12. Known allergy to any of the materials used in the PerQseal Elite device (refer to Investigator's Brochure), 13. Subject is unsuitable for surgical repair of the target leg access site, 14. Subject has undergone a percutaneous procedure greater than 8F sheath in the target vessel, within the 90-days prior to index procedure, 15. Subject has undergone a percutaneous procedure of 8F sheath or less using an absorbable intravascular closure device for haemostasis, in the target vessel, within the 90-days prior to index procedure, 16. 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 vessel, within the 30-days prior to index procedure, 17. History of DVT or pulmonary embolism or venous thrombotic event, 18. Splenectomy or suffering psoriasis or paraesthesia of the ipsilateral leg, 19. Further planned endovascular/catheter-based procedure in the target leg in the 30-days following the index procedure, 20. Subject is enrolled in another investigational medical device or drug study, 21. Subject has been previously enrolled in this clinical study, 22. Subject is unable to maintain ipsilateral leg still during the index procedure (restless leg syndrome), 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint- Combined rate of both Major and Minor access site complications | through 30 Days | the combined rate of both Major and Minor access site complications attributable to the PerQseal Elite device§ through 30-days, as adjudicated by the Clinical Events Committee (CEC) as study device related. |
| Primary Effectiveness Endpoint - Time to Haemostasis | 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 vein (CFV) bleeding (clinically acceptable cessation of venous bleeding), excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. This is assessed at the end of the index procedure prior leaving the operating room/catheterisation laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint -Time to Device Deployment (TTDD) | 20 Minutes | Time to Device Deployment is defined as the time from insertion of the PerQseal Elite delivery device into the PerQseal Elite Introducer sheath to complete removal of the PerQseal Elite (delivery device and introducer-sheath) from the subject following PerQseal Elite deployment. |
| Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate | 10 Minutes | PerQseal Elite Technical Success Rate is defined as the number of PerQseal Elite devices that are deployed and achieve haemostasis (i.e., cessation of venous bleeding excluding cutaneous or subcutaneous oozing) without need for more than 10 minutes of firm, adjunctive manual compression or alternative treatment (other than adjunctive endovascular ballooning) at target access site, divided by the total number of PerQseal Elite devices where deployment was attempted. |
| Secondary Effectiveness Endpoint - Total Closure Time | 40 Minutes | Total Closure Time is defined as: Time to Haemostasis (TTH) plus Time to Device Deployment (TTDD). |
| Secondary Effectiveness Endpoint - Time to Ambulation | through 24 hours | Time to Ambulation is defined as: the elapsed time from PerQseal Elite removal from the subject post deployment until the subject can walk 20 feet/6 meters without venous re-bleeding at the target access site. This endpoint will be evaluated only for subjects who are ambulatory (e.g., not confined to wheelchair or bed) at the time of enrolment. |
| Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate | through 30 days | PerQseal Elite Treatment Success Rate is defined as the number of subjects who meet PerQseal Elite Technical Success without experiencing a device related Access Site Complication (based on CEC adjudication) through 30-days, divided by the total number of subjects where PerQseal Elite device deployment was attempted. |
Countries
Netherlands
Contacts
Primary ContactChris Martin
Outcome results
None listed