Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion (SCORE-CTO)

University of Luebeck

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Device: Everolimus-eluting bioresorbable vascular scaffold; Device: Everolimus-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02739685

15-373

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Bioresorbable vascular scaffold

Experimental group

Description:

Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion

Treatment:

Device: Everolimus-eluting bioresorbable vascular scaffold

Stent

Active Comparator group

Description:

Implantation everolimus-eluting stent in chronic total occlusion

Treatment:

Device: Everolimus-eluting stent