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

Coronary Artery Disease Clinical Trial

— SUGAR-EVE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02632292
• Other study ID #: 15-260
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 3, 2017

Study information

• Verified date: September 2019
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: January 3, 2017
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes Mellitus

Intervention

Device:
• Absorb GT1
Bioresorbable vascular scaffold
• Promus
Everolimus-eluting stent

Locations

Country	Name	City	State
Germany	University of Luebeck	Luebeck

Sponsors (4)

Lead Sponsor	Collaborator
University of Luebeck	Charite University, Berlin, Germany, Kerckhoff Klinik, University of Schleswig-Holstein, Campus Kiel, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late lumen loss		Angiography 8-10 months after the index procedure
Secondary	Device success	Attainment of <30% final residual stenosis following the index procedure.	Baseline angiography
Secondary	Procedure success	Device success and no periprocedural complications.	Baseline angiography
Secondary	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
Secondary	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
Secondary	Binary restenosis	In-stent or in-segment restenosis =50% assessed by angiography at 8-10 months.	Angiography 8-10 months after the index procedure
Secondary	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
Secondary	Major adverse cardiac events	Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization	12- and 24-months
Secondary	Cardiac death		12- and 24-months
Secondary	Myocardial infarction		12- and 24-months
Secondary	Scaffold/stent thrombosis		12- and 24-months
Secondary	Target vessel revascularization		12- and 24-months
Secondary	Target lesion failure	Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization	12- and 24-months
Secondary	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
Secondary	Clinical success	Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up	12- and 24-months
Secondary	Anginal status assessed by the Seattle Angina Questionnaire		12- and 24-months