Coronary Artery Disease, Diabetes Mellitus
Conditions
Brief summary
Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.
Interventions
DEVICEAbsorb GT1
Bioresorbable vascular scaffold
DEVICEPromus
Everolimus-eluting stent
Sponsors
University Hospital Schleswig-Holstein
Kerckhoff Klinik
Charite University, Berlin, Germany
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss | Angiography 8-10 months after the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | Baseline angiography | Device success and no periprocedural complications. |
| Vasomotion | 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 | 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 | Angiography 8-10 months after the index procedure | In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months. |
| Conformability | 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 | 12- and 24-months | Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization |
| Cardiac death | 12- and 24-months | — |
| Device success | Baseline angiography | Attainment of \<30% final residual stenosis following the index procedure. |
| Scaffold/stent thrombosis | 12- and 24-months | — |
| Target vessel revascularization | 12- and 24-months | — |
| Target lesion failure | 12- and 24-months | Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization |
| Target vessel failure | 12- and 24-months | Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis |
| Clinical success | 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 | 12- and 24-months | — |
| Myocardial infarction | 12- and 24-months | — |
Countries
Germany
Outcome results
None listed