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

U

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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