EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsu... | NCT02632292

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

NCT02632292

Sponsor

University of Luebeck

Status

Terminated

Last Update Posted

Sep 26, 2019Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease
Diabetes Mellitus

Interventions

Absorb GT1
Promus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Jan 3, 2017Actual

Completion Date

Jan 3, 2017Actual

First Submitted Date

Dec 3, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2019

Last Update Posted Date

Sep 26, 2019Actual

Name	Class
University Hospital Schleswig-Holstein	OTHER
Kerckhoff Klinik	OTHER
Charite University, Berlin, Germany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Absorb GT1	Experimental	Bioresorbable everolimus-eluting scaffolds	Device: Absorb GT1
Promus	Active Comparator	Everolimus-eluting stents	Device: Promus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Absorb GT1	Device	Bioresorbable vascular scaffold	Absorb GT1
Promus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Luebeck		Lübeck		23538	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided