Percutaneous Large Hole Vascular Closure
Conditions
Keywords
vascular closure, vascular closure device, large hole percutaneous closure, large bore percutaneous closure
Brief summary
The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.
Detailed description
This study is a prospective, multi-center, single arm EFS. Patients undergoing a percutaneous trancatheter procedure, requiring an arteriotomy created by 14 - 22 F sheaths (arteriotomies up to approx. 26 F), via the common femoral artery will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent, and shall subsequently be assigned a study ID number. Enrollment will occur at the point where the PerQseal®+ VCD study device first enters the patient's body. The planned enrollment is 15 treated patients at a maximum of 5 study sites (minimum of 3) located in the United States.
Interventions
DEVICEPerQseal Plus Device
Percutaneous closure of femoral artery access site created by 14 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing Percutaneous Transcatheter procedures.
Sponsors
Vivasure Medical Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Early Feasibility Study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Age ≥ 19 years, 2. Clinically indicated for a large bore interventional transcatheter procedure, e.g., transcatheter aortic valve repair (TAVR) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) using a percutaneous common femoral arteriotomy created by a 14 to 22 F sheath, 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 |
|---|---|---|
| Safety: Major Access Site Complications | though 30 days | The primary safety endpoint is the rate of major access site complications attributable to the PerQseal® device. As per FDA definitions for Major access site complications. |
| Efficacy: Time to Haemostasis | 20 minutes | Elapsed time in minutes from PerQseal® Introducer sheath removal to first observed cessation of common femoral artery (CFA) bleeding (excluding cutaneous or subcutaneous oozing, and in the absence of a developing hematoma). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence of Minor Access Site Complications | through 30 days | Incidence and severity of minor access site complications attributable to the PerQseal® device, adapted from FDA-provided definitions. |
| Efficacy: PerQseal® Device Technical Success Rate | 10 minutes | PerQseal® Device Technical Success Rate, defined as the number of PerQseal® devices that are deployed and achieve hemostasis (i.e., cessation of bleeding (excluding cutaneous or subcutaneous oozing)) without need for firm, adjunctive manual compression for greater than 10 minutes or alternative treatment (other than adjunctive endovascular ballooning) at target access site, divided by the total number of PerQseal® devices where deployment was attempted. |
| Efficacy: PerQseal® Treatment Success Rate | through 30 days | PerQseal® Treatment Success Rate, defined as the number of subjects who meet PerQseal® Device Technical Success without experiencing a Major Access Site Complication, divided by the total number of subjects where PerQseal® device deployment was attempted. |
| Efficacy: Time to Device Deployment | 20 minutes | Time to Device Deployment, defined as the time from insertion of the PerQseal® device into the PerQseal Introducer sheath to complete removal of the PerQseal® device delivery system and PerQseal® Introducer sheath from the subject following PerQseal® deployment. |
| Efficacy: Time to Ambulation | through 5 day | Time to Ambulation is defined as: the elapsed time from PerQseal® + removal until the subject can walk 20 feet without re-bleeding at the target access site. This endpoint will be evaluated only for subjects who are ambulatory at the point of enrollment. |
| Efficacy: Total Closure Time | 40 minutes | Total Closure Time is defined as: Time to Hemostasis (TTH) plus Time to Device Deployment |
Countries
United States
Outcome results
None listed