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

September 24, 2019 updated by: Holger Thiele, University of Luebeck

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Luebeck, Germany, 23538
        • University of Luebeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent late lumen loss assessed by angiography
Time Frame: 8-10 months after the index procedure
8-10 months after the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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