Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Everolimus-eluting stent; Device: Everolimus-eluting bioresorbable vascular scaffold

• Registration Number: NCT02739685
• Lead Sponsor: University of Luebeck

Brief Summary

The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-15
• Study Start: 2016-09
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Clinical inclusion criteria:

• Age ≥18 years
• Angina pectoris, equivalent symptoms, and/or positive stress test
• Viable myocardium subtended by chronic total occlusion
• Negative pregnancy test in women with childbearing potential

Angiographic inclusion criteria:

• Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months
• Successful wire passage and assumption of successful stent/scaffold deployment
• Target reference vessel diameter 2.5 - 4.0 mm

Exclusion Criteria

Clinical exclusion criteria:

• Limited long-term prognosis with a life-expectancy <12 months
• Contraindications to antiplatelet therapy
• Known allergy against cobalt chrome, everolimus, or polylactic acid

Angiographic exclusion criteria:

• Target lesion located in the left main trunk
• Target lesion located in a coronary bypass graft
• Bifurcation lesion with planned two-stent strategy
• Indication for coronary artery bypass grafting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent	Everolimus-eluting stent	Implantation everolimus-eluting stent in chronic total occlusion
Bioresorbable vascular scaffold	Everolimus-eluting bioresorbable vascular scaffold	Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion

Primary Outcome Measures

Name	Time	Method
In-stent late lumen loss assessed by angiography	8-10 months after the index procedure

Trial Locations

Locations (1)

University of Luebeck; 🇩🇪 Luebeck, Germany