Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

Coronary Artery Disease Clinical Trial

— SCORE-CTO  

Official title:

Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02739685
• Other study ID #: 15-373
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: September 2019
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Everolimus-eluting bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
• Everolimus-eluting stent
Implantation of everolimus-eluting stent in chronic total occlusion

Locations

Country	Name	City	State
Germany	University of Luebeck	Luebeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late lumen loss assessed by angiography		8-10 months after the index procedure