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

NCT ID: NCT03847233

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2020-05-20

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jetstream Atherectomy System

Group Type: EXPERIMENTAL

Jetstream Atherectomy System

Intervention Type: DEVICE

A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA

Interventions

Jetstream Atherectomy System

A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA

Intervention Type: DEVICE

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 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazushi Urasawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokeidai Memorial Hospital

Locations

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Kokura Memorial Hospital

Kokura, Fukuoka, Japan

Tokeidai Memorial Hospital

Sapporo, Hokkaido, Japan

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

S2450

Identifier Type: -

Identifier Source: org_study_id