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EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus (SUGAR-EVE)

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Absorb GT1
Promus
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Luebeck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Absorb GT1

Promus

Arm Description

Bioresorbable everolimus-eluting scaffolds

Everolimus-eluting stents

Outcomes

Primary Outcome Measures

In-stent late lumen loss

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2015
Last Updated
September 24, 2019
Sponsor
University of Luebeck
Collaborators
University of Schleswig-Holstein, Campus Kiel, Germany, Kerckhoff Klinik, Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02632292
Brief Title
EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
Acronym
SUGAR-EVE
Official Title
EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 3, 2017 (Actual)
Study Completion Date
January 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
University of Schleswig-Holstein, Campus Kiel, Germany, Kerckhoff Klinik, Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absorb GT1
Arm Type
Experimental
Arm Description
Bioresorbable everolimus-eluting scaffolds
Arm Title
Promus
Arm Type
Active Comparator
Arm Description
Everolimus-eluting stents
Intervention Type
Device
Intervention Name(s)
Absorb GT1
Intervention Description
Bioresorbable vascular scaffold
Intervention Type
Device
Intervention Name(s)
Promus
Intervention Description
Everolimus-eluting stent
Primary Outcome Measure Information:
Title
In-stent late lumen loss
Time Frame
Angiography 8-10 months after the index procedure
Secondary Outcome Measure Information:
Title
Device success
Description
Attainment of <30% final residual stenosis following the index procedure.
Time Frame
Baseline angiography
Title
Procedure success
Description
Device success and no periprocedural complications.
Time Frame
Baseline angiography
Title
Vasomotion
Description
Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months.
Time Frame
Angiography 8-10 months after the index procedure
Title
In-segment late lumen loss
Description
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.
Time Frame
Angiography 8-10 months after the index procedure
Title
Binary restenosis
Description
In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.
Time Frame
Angiography 8-10 months after the index procedure
Title
Conformability
Description
Change in curvature and angulation between preprocedure, postprocedure, and angiographic follow-up at 8-10 months.
Time Frame
Angiography 8-10 months after the index procedure
Title
Major adverse cardiac events
Description
Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization
Time Frame
12- and 24-months
Title
Cardiac death
Time Frame
12- and 24-months
Title
Myocardial infarction
Time Frame
12- and 24-months
Title
Scaffold/stent thrombosis
Time Frame
12- and 24-months
Title
Target vessel revascularization
Time Frame
12- and 24-months
Title
Target lesion failure
Description
Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization
Time Frame
12- and 24-months
Title
Target vessel failure
Description
Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis
Time Frame
12- and 24-months
Title
Clinical success
Description
Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up
Time Frame
12- and 24-months
Title
Anginal status assessed by the Seattle Angina Questionnaire
Time Frame
12- and 24-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

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

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