CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Jetstream Atherectomy Systemdevice
Likely dose
Jetstream Atherectomy System (device parameters not specified in available text)AI-extracted
Key inclusion· 7
  • ✓Chronic symptomatic lower limb ischemia classified as Rutherford categories 2-4
  • ✓Stenotic, restenotic, or occlusive lesion in native superficial femoral artery and/or proximal popliteal artery with ≥70% stenosis or complete occlusion
  • ✓Target vessel diameter between 3.0 mm and 6.0 mm
  • ✓Total lesion length ≤150 mm (single or multiple lesions in series)
Key exclusion· 16
  • ✕In-stent restenosis in target lesion or vessel
  • ✕Prior drug-coated balloon treatment of target lesion within 12 months
  • ✕Prior stent placement, atherectomy, laser, or debulking device in target lesion
  • ✕SFA/PPA surgery or endovascular intervention in target vessel within 3 months for atherosclerotic disease

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

Search/NCT02733653
NCT02733653N/ACompleted
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Apr 11, 2016·Updated Jan 8, 2019

In Brief

A clinical study evaluating Jetstream Atherectomy System for Peripheral Arterial Disease. Completed, enrolled 60 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 11, 2016
Enrollment StartMay 25, 2016
Primary CompletionJun 29, 2017
Study CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.2 years ago

Interventions

Jetstream Atherectomy Systemdevice

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