CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Jetstream Atherectomy Systemdevice
Likely dose
Jetstream Atherectomy System — A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombusAI-extracted
Key inclusion· 5
  • ✓Chronic, symptomatic lower limb ischemia with Rutherford classification 2-4
  • ✓Stenotic, restenotic or occlusive lesion in native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA)
  • ✓Severely calcified lesions with ≥70% degree of stenosis
  • ✓Target vessel diameter between 3.0 and 6.0 mm
Key exclusion· 11
  • ✕In-stent restenosis in target lesion/vessel
  • ✕History of major amputation in the target limb
  • ✕History of coagulopathy or hypercoagulable bleeding disorder
  • ✕Untreatable hemorrhagic disease or platelet count <80,000/mm³ or >600,000/mm³

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

Search/NCT03847233
NCT03847233N/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 Feb 20, 2019·Updated Aug 16, 2021

In Brief

A clinical study evaluating Jetstream Atherectomy System for Peripheral Arterial Disease. Completed, enrolled 31 participants across 5 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
20192020202120222023202420252026
First PostedFeb 20, 2019
Enrollment StartMar 19, 2019
Primary CompletionNov 8, 2019
Study CompletionMay 20, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.4 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