Coronary Artery DiseaseSUGAR-EVENCT02632292
EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
A study testing Absorb GT1 and Promus in people with Coronary Artery Disease and Diabetes Mellitus, run by University of Luebeck at 1 site in Germany.
Trial summary
Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Absorb GT1 and Promus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to 3 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
Clinical inclusion criteria:
- Age ≥18 years
- DM type I or II based on the definitions of the American Diabetes Association
- Angiographically proven CAD
- Angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80
- Negative pregnancy test in women with childbearing potential
Angiographic inclusion criteria:
- De-novo lesion in at least one native coronary artery
- Luminal diameter reduction 50-99% assessed by visual estimation
- Target reference vessel diameter 2.5 - 4.0 mm
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
- Severe calcification of the target lesion as determined by angiography
- In-stent restenosis
- Bifurcation lesion with planned two-stent strategy
- Chronic total occlusion
- Indication for CABG
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Absorb GT1, Promus
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorb GT1Device
Bioresorbable vascular scaffold
PromusDevice
Everolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Absorb GT1 | Experimental | Bioresorbable everolimus-eluting scaffolds Receives: Device: Absorb GT1 |
| Promus | Active comparator | Everolimus-eluting stents Receives: Device: Promus |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss
Measured: Angiography 8-10 months after the index procedure
Secondary outcomes (15)
Device success
Attainment of <30% final residual stenosis following the index procedure.
Measured: Baseline angiography
Procedure success
Device success and no periprocedural complications.
Measured: Baseline angiography
Vasomotion
Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months.
Measured: Angiography 8-10 months after the index procedure
In-segment late lumen loss
Difference between the immediate post-procedure in-stent minimal lumen diameter and the in-stent minimal lumen diameter assessed by angiography at 8-10 months inside the stent or within 5 mm proximal or distal to the stent.
Measured: Angiography 8-10 months after the index procedure
Binary restenosis
In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.
Measured: Angiography 8-10 months after the index procedure
Conformability
Change in curvature and angulation between preprocedure, postprocedure, and angiographic follow-up at 8-10 months.
Measured: Angiography 8-10 months after the index procedure
Major adverse cardiac events
Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization
Measured: 12- and 24-months
Cardiac death
Measured: 12- and 24-months
Myocardial infarction
Measured: 12- and 24-months
Scaffold/stent thrombosis
Measured: 12- and 24-months
Target vessel revascularization
Measured: 12- and 24-months
Target lesion failure
Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization
Measured: 12- and 24-months
Target vessel failure
Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis
Measured: 12- and 24-months
Clinical success
Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up
Measured: 12- and 24-months
Anginal status assessed by the Seattle Angina Questionnaire
Measured: 12- and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Why it stopped: Slow enrollment
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein, Kerckhoff Klinik, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Holger Thiele, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632292
- Sponsor's protocol ID
- 15-260
- Acronym
- SUGAR-EVE
- Status last verified
- Sep 2019
- First submitted
- 3 Dec 2015
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
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 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02632292
- Acronym / sponsor ID
- SUGAR-EVE / 15-260
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein, Kerckhoff Klinik, Charite University, Berlin, Germany
- Study start
- Jan 2016 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 16 Dec 2015 (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.
Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorb GT1 | Experimental | Device: Absorb GT1Bioresorbable everolimus-eluting scaffolds |
| Promus | Active comparator | Device: PromusEverolimus-eluting stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Absorb GT1Bioresorbable vascular scaffold | Device | Absorb GT1 |
| PromusEverolimus-eluting stent | Device | Promus |
Primary outcome
In-stent late lumen loss
Time frame: Angiography 8-10 months after the index procedure
15 secondary outcomes
Device success
Time frame: Baseline angiography
Procedure success
Time frame: Baseline angiography
Vasomotion
Time frame: Angiography 8-10 months after the index procedure
In-segment late lumen loss
Time frame: Angiography 8-10 months after the index procedure
Binary restenosis
Time frame: Angiography 8-10 months after the index procedure
Conformability
Time frame: Angiography 8-10 months after the index procedure
Major adverse cardiac events
Time frame: 12- and 24-months
Cardiac death
Time frame: 12- and 24-months
Myocardial infarction
Time frame: 12- and 24-months
Scaffold/stent thrombosis
Time frame: 12- and 24-months
Target vessel revascularization
Time frame: 12- and 24-months
Target lesion failure
Time frame: 12- and 24-months
Target vessel failure
Time frame: 12- and 24-months
Clinical success
Time frame: 12- and 24-months
Anginal status assessed by the Seattle Angina Questionnaire
Time frame: 12- and 24-months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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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 Absorb GT1 and Promus in people with Coronary Artery Disease and Diabetes Mellitus, 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?
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). 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 (time frame: Angiography 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.