Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)

Boston Scientific

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Jetstream Atherectomy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02733653

S6051

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal arteries (PPA).

Full description

A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.

Enrollment

60 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet all of the following criteria:
- Calcified lesions with degree of stenosis ≥70% or occlusions
- Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
- Vessel diameter ≥3.0 mm and ≤6.0 mm
- Total lesion length (or series of lesions) ≤150mm
- Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate
Patent infrapopliteal and popliteal artery

Exclusion criteria

Target lesion/vessel with in-stent restenosis
Target lesion/vessel previously treated with drug-coated balloon <12 months prior to the procedure
Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure
Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure
Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure
History of major amputation in the target limb
Subject has a history of coagulopathy or hypercoagulable bleeding disorder
Subject with untreatable hemorrhagic disease or platelet count <80,000mm3 or >600,000mm3 as baseline assessment.
Concomitant renal failure with a serum creatinine >2.0 mg/dL
Receiving dialysis or immunosuppressant therapy
History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment
Unstable angina pectoris at the time of the enrollment
Septicemia at the time of enrollment
Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
Presence of aneurysm in the target vessel
Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure
Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure