NCT00987324

Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

Detailed description

The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus. Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions. The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.

Conditions

• Heart Disease
• Ischemia
• Restenosis

Interventions

Type	Name	Description
DEVICE	Taxus stent	Implantation of paclitaxel-eluting stent
DEVICE	SeQuent Please	Dilation with SeQuent Please (paclitaxel-eluting balloon)
DEVICE	Conventional Balloon Catheter	Ryuijin, Trek

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• Completion: 2013-10-01
• First posted: 2009-09-30
• Last updated: 2016-11-21

Locations

3 sites across 1 country: Germany