COMPARE-II- Vasomotion and Imaging Substudy | NCT01329237

Studies
COMPARE-II- Vasomotion and Imaging Substudy

NCT01329237

Sponsor

University of Freiburg

Status

Unknown status

Last Update Posted

Apr 5, 2011Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

dynamic physical exercise and OCT imaging

Countries

Switzerland

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Apr 4, 2011

First Posted Date

Apr 5, 2011Estimated

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

Apr 4, 2011

Last Update Posted Date

Apr 5, 2011Estimated

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

The purpose of the study is to compare strut coverage and neointimal thickness between everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation and to determine the coronary endothelial function after everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation by using supine bicycle exercise testing to assess coronary vasomotor response to exercise.

Detailed Description

DESIGN:

Imaging and vasomotion Substudy:

50 consecutive patients enrolled in the COMPARE II trial at the University of Fribourg Medical Center will undergo follow-up re-angiography 14 months after index procedure with assessment of Optical coherence tomography (OCT) and vasomotion testing.

ENDPOINT SUBSTUDY (all at 14 months):

Primary endpoint imaging: percentage of uncovered stent struts per lesion and mean neointimal thickness assessed by OCT.

vasomotion: coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dynamic physical exercise OCT	Other	dynamic physical exercise and optical coherence tomography imaging	Other: dynamic physical exercise and OCT imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dynamic physical exercise and OCT imaging	Other	supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent	dynamic physical exercise OCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of uncovered stent struts per lesion assessed by OCT		within 14 months after percutaneous coronary stent implantation

Secondary Outcomes

Measure	Description	Time Frame
coronary vasomotor function	coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise	within 14 months after stentimplantation
mean neointimal thickness assessed by OCT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient enrolled in the COMPARE II trial with successful stent implantation and absence of binary restenosis or severe progression of coronary artery disease at 14 months follow-up.
Patient consent to undergo a non-scheduled follow- up angiography with imaging study and bicycle exercise testing

Exclusion Criteria:

Inability to provide informed consent
Inability to perform a supine bicycle exercise stress test
Binary in stent restenosis of the target vessel
Acute Coronary Syndrome, Acute Myocardial Infarction
Patients with stent thrombosis following the index procedure
Female of childbearing potential ( age ≤ 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy
Known intolerance to heparin, contrast material
History of bleeding diathesis or known coagulopathy
Age ≥ 80 years
Hemodynamic instability
Renal failure (creatinine clearance ≤ 40 ml/min)
OCT / IVUS technically not feasible

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mario Togni, MD	Contact	++41-26-426-8130		mario.togni@unifr.ch
Stéphane Cook, MD	Contact	++41-26-426-8130		stephane.cook@unifr.ch

Overall Officials

Name	Affiliation	Role
Mario Togni, MD	University of Fribourg, Switzerland	Principal Investigator
Stéphane Cook, MD	University of Fribourg, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Cantonal HFR	Recruiting	Fribourg	Canton of Fribourg	1708	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

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

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Browse Branches

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