Coronary Artery DiseaseSCORE-CTONCT02739685
Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
A study testing Everolimus-eluting bioresorbable vascular scaffold and Everolimus-eluting stent in people with Coronary Artery Disease, run by University of Luebeck at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Everolimus-eluting bioresorbable vascular scaffold and Everolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- Target lesion located in a coronary bypass graft
- Bifurcation lesion with planned two-stent strategy
- Indication for coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Everolimus-eluting bioresorbable vascular scaffold, Everolimus-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus-eluting bioresorbable vascular scaffoldDevice
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Everolimus-eluting stentDevice
Implantation of everolimus-eluting stent in chronic total occlusion
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion Receives: Device: Everolimus-eluting bioresorbable vascular scaffold |
| Stent | Active comparator | Implantation everolimus-eluting stent in chronic total occlusion Receives: Device: Everolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss assessed by angiography
Measured: 8-10 months after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Slow enrollment, access to devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Thiele, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739685
- Sponsor's protocol ID
- 15-373
- Acronym
- SCORE-CTO
- Status last verified
- Sep 2019
- First submitted
- 13 Apr 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT02739685
- Acronym / sponsor ID
- SCORE-CTO / 15-373
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment, access to devices
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Device: Everolimus-eluting bioresorbable vascular scaffoldImplantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion |
| Stent | Active comparator | Device: Everolimus-eluting stentImplantation everolimus-eluting stent in chronic total occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months
Key exclusion criteria (9 listed)
- Limited long-term prognosis with a life-expectancy <12 months
- Contraindications to antiplatelet therapy
- Known allergy against cobalt chrome, everolimus, or polylactic acid
- Target lesion located in the left main trunk
- Target lesion located in a coronary bypass graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus-eluting bioresorbable vascular scaffoldImplantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion | Device | Bioresorbable vascular scaffold |
| Everolimus-eluting stentImplantation of everolimus-eluting stent in chronic total occlusion | Device | Stent |
Primary outcome
In-stent late lumen loss assessed by angiography
Time frame: 8-10 months after the index procedure
Results and safety
The study was stopped early (reason given: Slow enrollment, access to devices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everolimus-eluting bioresorbable vascular scaffold and Everolimus-eluting stent in people with Coronary Artery Disease, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment, access to devices). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent late lumen loss assessed by angiography (time frame: 8-10 months after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.