Large Hole Percutaneous Arterial Closure
Conditions
Keywords
Arterial closure, Percutaneous arterial closure, Large hole arterial closure, Large bore arterial closure
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.
Interventions
DEVICEPerQseal ELITE
Percutaneous ELITE Arterial Closure Device 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 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). 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
Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Major access site complications | through 30 Days | Rate of major access site complications attributable to the PerQseal Elite device |
| 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 artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate | through 30 days | Defined as the number of subjects who meet PerQseal Elite Technical Success without experiencing a device related Major Access Site Complication (based on CEC adjudication) through 30-days, divided by the total number of subjects where PerQseal Elite device deployment was attempted, within the mITT population. |
| Secondary Effectiveness Endpoint - Time to Device Deployment | 20 Minutes | 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 Safety Endpoint - Incidence of Minor Access Site Complications | Through 30 Days | The Incidence of minor access site complications attributable to the PerQseal Elite device |
| 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 | Defined as the elapsed time from PerQseal Elite removal from the subject post deployment until the subject can walk 20 feet/6 meters without arterial 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 Technical Success Rate | 10 Minutes | Defined as the number of PerQseal Elite devices that are deployed and achieve haemostasis (i.e., cessation of arterial 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, within the mITT population |
Contacts
Primary ContactChris Martin
Outcome results
None listed