Percutaneous Large Hole Vascular Closure
Conditions
Keywords
vascular closure, arterial closure, vascular closure device, large hole percutaneous closure, large bore percutaneous closure
Brief summary
The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI. Closure of femoral arterial access sites created with 13 to 14 F sheaths will be studied, assessing the need for alternative therapy other than manual compression or adjunctive endovascular ballooning.
Detailed description
This study is a prospective, multi-center, single arm EFS. Patients undergoing use of an Impella device for cardiogenic shock or PPCI, requiring an arteriotomy created by 13 to 14 F sheaths (arteriotomies up to approx. 18 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 study device first enters the patient's body. The planned enrollment is a minimum of 20 treated patients at a maximum of 5 study sites located in the United States.
Interventions
DEVICEPPCI
Closure of the femoral access site with PerQseal device at the end of the PPCI index procedure and removal of the Impella pump.
DEVICECardiogenic shock
Closure of the femoral access site with PerQseal device after removal of the Impella pump.
Sponsors
Vivasure Medical Limited
Study design
Allocation
NON_RANDOMIZED
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. Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected percutaneous coronary intervention (PPCI) or cardiogenic shock, 3. Duration of Impella use \> 8 hours and ≤ 4 days if used for cardiogenic shock 4. Duration of Impella use ≤ 6 hours if used for PPCI. 5. Impella access sheath between 13 and 14 F, 6. Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent, 7. 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 systemic bacterial or cutaneous infection, including groin infection, 2. 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, 3. Significant anemia (hemoglobin \<9 g/dL or hematocrit \< 27%), within 24 hours prior to index procedure, 4. Known type II heparin-induced thrombocytopenia, 5. Unilateral or bilateral lower extremity amputation. 6. Rest pain (e.g., Rutherford category 4 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, 7. Known existing nerve damage in the target leg, 8. Known allergy to any of the materials used in the PerQseal® device (refer to Instructions for Use), 9. Subject unsuitable for surgical repair of the target leg access site, 10. Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90 days prior to index procedure, 11. Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable or suture mediated closure device for hemostasis, in the target vessel, within the 90 days prior to index procedure, 12. Prior evidence of anterior calcification within 10 mm proximal or distal to arteriotomy site, 13. Target femoral artery diameter is less than 6 mm in diameter, 14. Subject is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up, 15. Subject has been previously enrolled in this clinical study. 16. Current COVID-19 infection (with or without symptoms), recent positive test for COVID-19, or recent exposure to a person with COVID-19 infection. Procedural
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Major Access Site Complications | through 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 Hemostasis | 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 |
|---|---|---|
| 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. |
| 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: Overall Procedural Time | 4 days | Overall Procedural Time, defined as the time from first invasive contact with the subject's groin to completion of all aseptic procedures related to the groin and index procedure. |
| 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: 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. |
Countries
United States
Outcome results
None listed