NCT02936011

DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in CTO.

DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in Chronic Total Occlusion. The DISCRETE CTO Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Belfast Health and Social Care Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CTO PCI using Absorb Bioresorbable Vascular Scaffolds	CTO PCI

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-03-01
• Completion: 2019-03-01
• First posted: 2016-10-18
• Last updated: 2016-10-18

Locations

1 site across 1 country: United Kingdom