Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
DEVICEJETi 6F and 8F Thrombectomy system
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.
Sponsors
ID3 Medical
Abbott
Vascular Science LP GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient is ≥18 years * Patient has Rutherford Classification 2,3 or 4. * Patient has provided written informed consent and is willing to comply with study follow-up requirements. Angiographic inclusion criteria * De novo thrombotic occlusive lesion(s) or thrombotic re-occlusion or in-stent thrombotic occlusive lesion(s) or thrombotic occlusion of a bypass (autolog or prosthetic) occurring acute or subacute with onset of complains within \<30 days prior to first seen by investigating physician. * Target lesion is located between the ostium of the SFA and the end of the P3 segment of the popliteal artery, tibioperoneal trunk, respectively the first 10 cm of the below the knee vessels * Target vessel diameter ≥ 3 mm and ≤ 8 mm and irrespective of lesion length * Target lesion must be occlusive lesion Note: there is no limitation in lesion length * Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen. * A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography. * At least one patent native distal outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.
Exclusion criteria
* Patients meets any contraindication for JETi mechanical thrombectomy use per IFU * Lesion crossing is difficult and the lesion is not suspicious for fresh thrombus containment * Pregnant women or female patients of childbearing potential that do not use adequate contraceptive methods * Patient has a life expectancy of less than 1 year * Patient has a known allergy to contrast medium that cannot be adequately pre-medicated. * Patient is allergic to all anti-platelet treatments * Patient has platelet count \<100.000/mm3 or \>700.000/mm * Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure * Patient is diagnosed with coagulopathy that bares the risk of increased bleeding risk * Patient has history of stroke within past 90 days * Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study. * Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure * Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol * Patient suffering from HIT II Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint | During index procedure | 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. |
| Primary Safety Endpoint | Up to 30 days post-index procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained clinical improvement at discharge and at 30- days post-index procedure | Hospital admission to discharge up to 30 days and at 30 days | 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) |
| Primary Patency at discharge and at 30 days post-index procedure | Hospital admission to discharge up to 30 days and at 30 days | 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 |
| Freedom from TLR at discharge and at 30 days post-index procedure | Hospital admission to discharge up to 30 days and at 30 days | 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 |
| Change in target limb Rutherford Classification from baseline to 30 days post-index procedure | Up to 30 days | Change in target limb Rutherford Classification from baseline to 30 days post-index procedure |
| Acute device success | During index procedure | Defined as successful delivery of the device to the lesion |
| Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure | 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 EQ-5D questionnaire from baseline to 30 days post-index procedure | Up to 30 days | Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure |
| Duration of hospital stay | Hospital admission to discharge up to 30 days | Duration of hospital stay |
| Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure | Up to 30 days | Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure |
| Secondary safety endpoint at discharge up to 30 days post index procedure | Up to 30 days | 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 |
Outcome results
None listed