Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

NCT02739685 | Terminated

• 1 other identifier: 15-373
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss assessed by angiography

  8-10 months after the index procedure

Study Arms (2)

Bioresorbable vascular scaffold

EXPERIMENTAL

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

Device: Everolimus-eluting bioresorbable vascular scaffold

Stent

ACTIVE COMPARATOR

Implantation everolimus-eluting stent in chronic total occlusion

Device: Everolimus-eluting stent

Interventions

Everolimus-eluting bioresorbable vascular scaffold DEVICE

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

Bioresorbable vascular scaffold

Everolimus-eluting stent DEVICE

Implantation of everolimus-eluting stent in chronic total occlusion

Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

University of Luebeck

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 15, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

DE (1)