Coronary Restenosis Clinical Trial
Official title:
Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH – ISR II)
The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical
trials. It may be preferable, however, to avoid the stent-in-stent approach in treating
in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant
reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the
PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.
Methods and results: The PACCOCATH ISR study is a randomized, double-blind German
multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are
randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm²
balloon surface) or a non-coated balloon of the same type (n=56 patients). Balloon inflation
time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery
with a diameter stenosis of at least 70%, < 30 mm length, and a vessel diameter of 2.5 to
3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic
core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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