Status:
COMPLETED
PerQseal® Impella Early Feasibility Study
Lead Sponsor:
Vivasure Medical Limited
Conditions:
Percutaneous Large Hole Vascular Closure
Eligibility:
All Genders
19+ years
Phase:
NA
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 ...
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 (arterioto...
Eligibility Criteria
Inclusion
- Age ≥ 19 years,
- Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected percutaneous coronary intervention (PPCI) or cardiogenic shock,
- Duration of Impella use \> 8 hours and ≤ 4 days if used for cardiogenic shock
- Duration of Impella use ≤ 6 hours if used for PPCI.
- Impella access sheath between 13 and 14 F,
- Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent,
- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
- Baseline
Exclusion
- Evidence of systemic bacterial or cutaneous infection, including groin infection,
- 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,
- Significant anemia (hemoglobin \<9 g/dL or hematocrit \< 27%), within 24 hours prior to index procedure,
- Known type II heparin-induced thrombocytopenia,
- Unilateral or bilateral lower extremity amputation.
- 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,
- Known existing nerve damage in the target leg,
- Known allergy to any of the materials used in the PerQseal® device (refer to Instructions for Use),
- Subject unsuitable for surgical repair of the target leg access site,
- Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90 days prior to index procedure,
- 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,
- Prior evidence of anterior calcification within 10 mm proximal or distal to arteriotomy site,
- Target femoral artery diameter is less than 6 mm in diameter,
- Subject is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up,
- Subject has been previously enrolled in this clinical study.
- 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
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04818541
Start Date
June 29 2021
End Date
March 1 2023
Last Update
April 26 2023
Active Locations (4)
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1
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
2
University of Buffalo
Buffalo, New York, United States, 14203
3
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
4
Montefiore Medical Center
The Bronx, New York, United States, 10467