Acute Coronary Syndrome Clinical Trial
Official title:
ISAR-DESIRE 4: Randomized Trial Of Scoring Balloon in Patients With Restenosis in "Limus"-Eluting Coronary Stents Undergoing Angioplasty With Paclitaxel-Coated Balloon
The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)
The optimal treatment of in-BMS-restenosis seems to be implantation of a DES which is
supported by a large body of evidence. Nevertheless, several recent published studies have
shown a substantial reduction in late lumen loss and angiographic restenosis using
paclitaxel-coated balloons (PCB) for restenotic lesions. Given the increased world-wide use
of DES and the use of DES in increasingly complex coronary disease patterns, the number of
patients presenting with restenosis after DES implantation will further increase in the
coming decade.
Data regarding the optimal treatment of in-DES-restenosis are very limited: Implanting a new
DES for in-DES-restenosis has been reported to associate with repeat restenosis rates as
high as 20%. In addition, an increased risk of stent thrombosis has been associated with
complex stenting and with additional DES implantation. Thus, for lesions which develop
restenosis after LES implantation, the optimal treatment strategy remains unknown.
Few results on small sample-size populations have been reported in patients treated with
scoring or cutting balloon (SCB) technology for treatment of BMS restenosis as compared to
plain balloon angioplasty. Moreover, the efficacy of SCB angioplasty in DES restenosis has
not been adequately addressed. Furthermore, the potential additive benefit of SCB
angioplasty in patients undergoing PCB therapy remains to be elucidated. The hypothesis
behind this concept is that the application of SCB prior to deployment of PCB may increase
the bioavailability of paclitaxel within the restenotic tissue, and therefore may increase
the efficacy of PCB. There are numerous preclinical studies to support this hypothesis,
which show that lesion preparation is an important pre-requisite for the effectiveness of
PCB.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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