Clinical trial NCT02632292: EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
Official title: EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes Mellitus
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
name: Kerckhoff Klinik
name: Charite University, Berlin, Germany
First posted: 2015-12-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: In-stent late lumen loss
timeFrame: Angiography 8-10 months after the index procedure
Secondary outcomes:
measure: Device success
timeFrame: Baseline angiography
measure: Procedure success
timeFrame: Baseline angiography
measure: Vasomotion
timeFrame: Angiography 8-10 months after the index procedure
measure: In-segment late lumen loss
timeFrame: Angiography 8-10 months after the index procedure
measure: Binary restenosis
timeFrame: Angiography 8-10 months after the index procedure
measure: Conformability
timeFrame: Angiography 8-10 months after the index procedure
measure: Major adverse cardiac events
timeFrame: 12- and 24-months
measure: Cardiac death
timeFrame: 12- and 24-months
measure: Myocardial infarction
timeFrame: 12- and 24-months
measure: Scaffold/stent thrombosis
timeFrame: 12- and 24-months
measure: Target vessel revascularization
timeFrame: 12- and 24-months
measure: Target lesion failure
timeFrame: 12- and 24-months
measure: Target vessel failure
timeFrame: 12- and 24-months
measure: Clinical success
timeFrame: 12- and 24-months
measure: Anginal status assessed by the Seattle Angina Questionnaire
timeFrame: 12- and 24-months
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University of Luebeck
Study officials:
References: