Coronary Artery Disease Clinical Trial
Official title:
Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®.
This is randomized-controlled trial of Absorb® Bioresorbable Vascular Scaffold (BVS) vs.
Sequent Please® drug coated balloon in an all-comers population with in-stent-restenosis
(ISR). The patients will be randomized in a 1:1 fashion and the investigators intend to
include 150 patients.
All patients presenting with ISR and requiring percutaneous coronary intervention will be
eligible to be included in this study. This will include patients with stable angina and
those presenting with acute coronary syndrome (ACS).
The primary objective of this study is to demonstrate superiority of the Absorb®
bioresorbable scaffold compared to the Sequent Please® Drug Coated Balloon when treating
patients with In-Stent-Restenosis regards to primary endpoint - angiographic late lumen loss
at 9 month follow-up.
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