MedTrace Logo

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

NCT03455855 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-10-29

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DEVICE

Jetstream System

including Atherectomy Console (Jetstream Console) and Atherectomy Catheter(Jetstream Catheter), 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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Wei Guo · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2023-02-22
Completion
2024-01-27
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455855 on ClinicalTrials.gov