NCT03847233CompletedNot Applicable
A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients With Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries
Boston Scientific Corporation5 sites in 1 country31 target enrollmentStarted: March 19, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 5
- Primary Endpoint
- Number of Patients With Lesion Success
Study Overview
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 native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA).
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 located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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 Criteria
- •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
Arms & Interventions
Jetstream Atherectomy System
Experimental
Intervention: Jetstream Atherectomy System (Device)
Outcomes
Primary Outcomes
Number of Patients With Lesion Success
Time Frame: during procedure
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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