EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.

Official Title
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EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus

Conditions
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Coronary Artery Disease, Diabetes Mellitus

Intervention / Treatment
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* Device: Absorb GT1
* Device: Promus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorb GT1<br>Bioresorbable everolimus-eluting scaffolds | Device: Absorb GT1<br>* Bioresorbable vascular scaffold<br>|
| Active Comparator: Promus<br>Everolimus-eluting stents | Device: Promus<br>* Everolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late lumen loss |  | Angiography 8-10 months after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | Attainment of <30% final residual stenosis following the index procedure. | Baseline angiography | 
| Procedure success | Device success and no periprocedural complications. | Baseline angiography | 
| Vasomotion | Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months. | 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. | Angiography 8-10 months after the index procedure | 
| Binary restenosis | In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months. | 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. | 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 | 12- and 24-months | 
| Cardiac death |  | 12- and 24-months | 
| Myocardial infarction |  | 12- and 24-months | 
| Scaffold/stent thrombosis |  | 12- and 24-months | 
| Target vessel revascularization |  | 12- and 24-months | 
| Target lesion failure | Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization | 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 | 12- and 24-months | 
| Clinical success | Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up | 12- and 24-months | 
| Anginal status assessed by the Seattle Angina Questionnaire |  | 12- and 24-months |