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EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus (SUGAR-EVE)
This study has been terminated.
(Slow enrollment)
Sponsor:
University of Luebeck
Collaborators:
University of Schleswig-Holstein, Campus Kiel, Germany
Kerckhoff Klinik
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Holger Thiele, University of Luebeck
ClinicalTrials.gov Identifier:
NCT02632292
First received: December 3, 2015
Last updated: April 12, 2017
Last verified: April 2017
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Purpose
Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
| Coronary Artery Disease Diabetes Mellitus | Device: Absorb GT1 Device: Promus | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Holger Thiele, University of Luebeck:
Primary Outcome Measures:
- In-stent late lumen loss [ Time Frame: Angiography 8-10 months after the index procedure ]
Secondary Outcome Measures:
- Device success [ Time Frame: Baseline angiography ]Attainment of <30% final residual stenosis following the index procedure.
- Procedure success [ Time Frame: Baseline angiography ]Device success and no periprocedural complications.
- Vasomotion [ Time Frame: Angiography 8-10 months after the index procedure ]Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months.
- In-segment late lumen loss [ Time Frame: Angiography 8-10 months after the index procedure ]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.
- Binary restenosis [ Time Frame: Angiography 8-10 months after the index procedure ]In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.
- Conformability [ Time Frame: Angiography 8-10 months after the index procedure ]Change in curvature and angulation between preprocedure, postprocedure, and angiographic follow-up at 8-10 months.
- Major adverse cardiac events [ Time Frame: 12- and 24-months ]Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization
- 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 ]Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization
- Target vessel failure [ Time Frame: 12- and 24-months ]Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis
- Clinical success [ Time Frame: 12- and 24-months ]Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up
- Anginal status assessed by the Seattle Angina Questionnaire [ Time Frame: 12- and 24-months ]
| Enrollment: | 33 |
| Study Start Date: | January 2016 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Absorb GT1
Bioresorbable everolimus-eluting scaffolds
|
Device: Absorb GT1
Bioresorbable vascular scaffold
|
|
Active Comparator: Promus
Everolimus-eluting stents
|
Device: Promus
Everolimus-eluting stent
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02632292
Please refer to this study by its ClinicalTrials.gov identifier: NCT02632292
Locations
| Germany | |
| University of Luebeck | |
| Luebeck, Germany, 23538 | |
Sponsors and Collaborators
University of Luebeck
University of Schleswig-Holstein, Campus Kiel, Germany
Kerckhoff Klinik
Charite University, Berlin, Germany
More Information
| Responsible Party: | Holger Thiele, Principal Investigator, University of Luebeck |
| ClinicalTrials.gov Identifier: | NCT02632292 History of Changes |
| Other Study ID Numbers: |
15-260 |
| Study First Received: | December 3, 2015 |
| Last Updated: | April 12, 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Coronary Artery Disease Myocardial Ischemia Coronary Disease Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases 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 |
ClinicalTrials.gov processed this record on July 14, 2017