Coronary Artery Disease Clinical Trial
Official title:
A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)
The primary objective of this study is determine the safety and performance of the Agent™
Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing
Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented
coronary arteries (in-stent restenosis).
The performance will be determined at six months post-procedure by quantitative coronary
angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA
results will be assessed by an independent, blinded angiographic core lab.
Study statistical hypothesis: The loss of in-stent luminal diameter at six months after
treatment of the restenosed stent with the Agent™ study device is not larger than the
respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is
non-inferior to the control device with respect to LLL.
n/a
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