CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Jetstream Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03455855
NCT03455855N/ACompleted

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

Boston Scientific Corporation·interventional·Posted Mar 7, 2018·Updated Oct 29, 2024

In Brief

A clinical study evaluating Jetstream System for Atherosclerosis. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartMar 5, 2018
Primary CompletionFeb 22, 2023
Study CompletionJan 27, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.3 years ago

Interventions

Jetstream Systemdevice

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.