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

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ClinicalTrials.gov Identifier: NCT02739685
Recruitment Status : Terminated (Slow enrollment, access to devices)
First Posted : April 15, 2016
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Everolimus-eluting bioresorbable vascular scaffold Device: Everolimus-eluting stent Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion
Study Start Date : September 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Device: Everolimus-eluting bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion

Active Comparator: Stent
Implantation everolimus-eluting stent in chronic total occlusion
Device: Everolimus-eluting stent
Implantation of everolimus-eluting stent in chronic total occlusion




Primary Outcome Measures :
  1. In-stent late lumen loss assessed by angiography [ Time Frame: 8-10 months after the index procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739685


Locations
Germany
University of Luebeck
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck

Responsible Party: Holger Thiele, Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck, University of Luebeck
ClinicalTrials.gov Identifier: NCT02739685     History of Changes
Other Study ID Numbers: 15-373
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents