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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
The Valley Hospital
Ridgewood, New Jersey, United States
Weill Cornell Medicine
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Montefiore Hospital
The Bronx, New York, United States
Safety: Major Access Site Complications
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.
Time frame: though 30 days
Efficacy: Time to Haemostasis
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).
Time frame: 20 minutes
Safety: Incidence of Minor Access Site Complications
Incidence and severity of minor access site complications attributable to the PerQseal® device, adapted from FDA-provided definitions.
Time frame: through 30 days
Efficacy: PerQseal® Device Technical Success Rate
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.
Time frame: 10 minutes
Efficacy: PerQseal® Treatment Success Rate
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.
Time frame: through 30 days
Efficacy: Time to Device Deployment
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Lankenau Heart Institute
Wynnewood, Pennsylvania, United States
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.
Time frame: 20 minutes
Efficacy: Time to Ambulation
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.
Time frame: through 5 day
Efficacy: Total Closure Time
Total Closure Time is defined as: Time to Hemostasis (TTH) plus Time to Device Deployment
Time frame: 40 minutes