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Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA

Atherosclerosis Clinical Trial

Official title:
Prospective, Non-randomized, Multicenter Clinical Study of the JETSTREAM™ Atherectomy System (Jetstream) in Treatment of Occlusive Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries in Chinese Patients

Clinical Trial Summary

This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.

Clinical Trial Description

study objectives: To evaluate the safety and effectiveness of JETSTREAM™ Atherectomy System (Jetstream) for treating symptomatic Chinese patients with occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA)during percutaneous peripheral vascular intervention. Planed Indications for use: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA. Primary Safety Endpoint: Major Adverse Event (MAE), defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure Primary Effectiveness Endpoint: Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03455855
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date March 5, 2018
Completion date January 27, 2024
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