Status:
COMPLETED
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 n...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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 the following criteria:
- Severely calcified lesions with degree of stenosis ≥70%
- Vessel diameter ≥3.0 mm and ≤6.0 mm
- Total lesion length (or series of lesions) ≤150 mm
Exclusion
- Target lesion/vessel with in-stent restenosis
- 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.
- 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
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03847233
Start Date
March 19 2019
End Date
May 20 2020
Last Update
August 16 2021
Active Locations (5)
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1
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan, 279-0001
2
Kokura Memorial Hospital
Kokura, Fukuoka, Japan, 802-8555
3
Tokeidai Memorial Hospital
Sapporo, Hokkaido, Japan, 060-0031
4
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan, 660-8511