NCT01722877

JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions

Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Midwest Cardiovascular Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.

Detailed description

Data not available yet.

Conditions

• Restenosis
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	JetStream Navitus	Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-08-01
• Completion: 2015-09-01
• First posted: 2012-11-07
• Last updated: 2020-03-03
• Results posted: 2017-05-05

Locations

2 sites across 1 country: United States