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

Phase 3

• Conditions: Peripheral Arterial Disease

• Registration Number: JPRN-UMIN000036056
• Lead Sponsor: Boston Scientific Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-01
• Study Completion: 2020-05-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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 <80,000 mm^3 or >600,000 mm^3 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified