Heart Disease Clinical Trial
Official title:
Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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