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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Everolimus-eluting bioresorbable vascular scaffold
Everolimus-eluting stent
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Luebeck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bioresorbable vascular scaffold

Stent

Arm Description

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

Implantation everolimus-eluting stent in chronic total occlusion

Outcomes

Primary Outcome Measures

In-stent late lumen loss assessed by angiography

Secondary Outcome Measures

Full Information

First Posted
April 13, 2016
Last Updated
September 24, 2019
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT02739685
Brief Title
Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
Acronym
SCORE-CTO
Official Title
Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment, access to devices
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioresorbable vascular scaffold
Arm Type
Experimental
Arm Description
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Arm Title
Stent
Arm Type
Active Comparator
Arm Description
Implantation everolimus-eluting stent in chronic total occlusion
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting bioresorbable vascular scaffold
Intervention Description
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent
Intervention Description
Implantation of everolimus-eluting stent in chronic total occlusion
Primary Outcome Measure Information:
Title
In-stent late lumen loss assessed by angiography
Time Frame
8-10 months after the index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

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