To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
Primary Efficacy Endpoint
The primary efficacy endpoint is technical procedural success (post Jeti) defined as restoration of impaired flow to a straight-line orthograde flow in the target vessel/bypass with near complete or complete recanalization of occluded vessel by using the JETI system prior to further additional endovascular therapy.
Time frame: During index procedure
Primary Safety Endpoint
The primary safety endpoint is a composite of 1. freedom from device- and procedure-related death through 30 days post-index procedure; 2. freedom from major target limb amputation (above-the-ankle (ATA)) through 30 days post-procedure and 3. freedom from clinically-driven target vessel revascularization (CD-TVR) through 30 days post-index procedure
Time frame: Up to 30 days post-index procedure
Acute device success
Defined as successful delivery of the device to the lesion
Time frame: During index procedure
Secondary safety endpoint at discharge up to 30 days post index procedure
Secondary safety endpoint is a composite of 1. freedom from Major Adverse Events (MAEs). MAEs are defined as: all-cause death; bleeding, hematoma and intracranial hemorrhage; major target limb amputation; thrombosis at the target lesion. 2. freedom from major target limb amputation and MALE 3. freedom from CD-TVR
Time frame: Up to 30 days
Sustained clinical improvement at discharge and at 30- days post-index procedure
Clinical improvement is defined as a composite of 1. freedom from major target limb amputation, 2. freedom from TVR, 3. freedom from worsening target limb Rutherford class (compared to baseline) 4. freedom from decrease in target limb ankle brachial index (ABI) ≥0.15 (compared to baseline)
Time frame: Hospital admission to discharge up to 30 days and at 30 days
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Primary Patency at discharge and at 30 days post-index procedure
The primary patency is defined as a composite of 1. freedom from clinically-driven target lesion revascularization (CD-TLR) 2. freedom from binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis) as confirmed by an independent Corelab
Time frame: Hospital admission to discharge up to 30 days and at 30 days
Freedom from TLR at discharge and at 30 days post-index procedure
TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure
Time frame: Hospital admission to discharge up to 30 days and at 30 days
Change in target limb Rutherford Classification from baseline to 30 days post-index procedure
Change in target limb Rutherford Classification from baseline to 30 days post-index procedure
Time frame: Up to 30 days
Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure
Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure
Time frame: Up to 30 days
Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure
Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure
Time frame: Up to 30 days
Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure
Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure
Time frame: Up to 30 days
Duration of hospital stay
Duration of hospital stay
Time frame: Hospital admission to discharge up to 30 days