Coronary Artery Disease Clinical Trial
Official title:
DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in Chronic Total Occlusion. The DISCRETE CTO Study.
Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular Scaffold (BVS).
This is a pilot study, with the aim of hypothesis generation. This research aims to
establish the feasibility and safety of treating chronic total occlusions using dissection
and re-entry techniques in combination with everolimus-eluting bioresorbable vascular
scaffolds (Absorb BVS).
Primary aims of the study are:
- To demonstrate a low rate of Target Vessel Failure (stent thrombosis, restenosis or
late closure) at 12 and 24 months after CTO PCI and stenting with the Absorb BVS
- To demonstrate a high degree of endothelial stent strut coverage at 12 and 24 moths
after CTO PCI and stenting with the Absorb BVSThe primary outcome measure is
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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