N/A
Completed N=50
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
Source: ClinicalTrials.gov NCT02733653 ↗Enrolled (actual)
50
Serious AEs
50.0%
Results posted
Sep 2018
Primary outcomePrimary: Primary Patency Rate — 19 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency Rate |
19 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02733653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.