NCT02733653

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Jetstream Atherectomy System	A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA

Timeline

• Start date: 2016-05-25
• Primary completion: 2017-06-29
• Completion: 2017-12-20
• First posted: 2016-04-11
• Last updated: 2019-01-08
• Results posted: 2018-09-10

Locations

10 sites across 1 country: Japan

Regulatory

• FDA-regulated device study