NCT01257438

FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

Prospective, Multi-Center, Randomized, Concurrently-Controlled Study of the FLUENCY® PLUS Endovascular Stent Graft in the Treatment of In-stent Restenosis in the Arteriovenous (AV) Access Venous Outflow Circuit (RESCUE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.

Detailed description

This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.

Conditions

• Restenosis

Interventions

Type	Name	Description
DEVICE	Fluency Plus Endovascular Stent Graft	Treatment of in-stent restenosis
DEVICE	Percutaneous Transluminal Angioplasty only	Treatment of in-stent restenosis

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-11-01
• Completion: 2016-01-01
• First posted: 2010-12-09
• Last updated: 2017-01-09
• Results posted: 2017-01-09

Locations

23 sites across 1 country: United States