Back to resultsCOMPARE-II- Vasomotion and Imaging Substudy (COMPARE-IT)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
dynamic physical exercise and OCT imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring drug-eluting stent, coronary endothelial function, coronary imaging
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
Sites / Locations
- Hopital Cantonal HFRRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
dynamic physical exercise OCT
Arm Description
dynamic physical exercise and optical coherence tomography imaging
Outcomes
Primary Outcome Measures
percentage of uncovered stent struts per lesion assessed by OCT
Secondary Outcome Measures
coronary vasomotor function
coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise
mean neointimal thickness assessed by OCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01329237
Brief Title
COMPARE-II- Vasomotion and Imaging Substudy
Acronym
COMPARE-IT
Official Title
Comparison of the Everolimus Eluting (XIENCE-V® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study The COMPARE II Trial Imaging and Vasomotion Substudy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Freiburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
drug-eluting stent, coronary endothelial function, coronary imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dynamic physical exercise OCT
Arm Type
Other
Arm Description
dynamic physical exercise and optical coherence tomography imaging
Intervention Type
Other
Intervention Name(s)
dynamic physical exercise and OCT imaging
Intervention Description
supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent
Primary Outcome Measure Information:
Title
percentage of uncovered stent struts per lesion assessed by OCT
Time Frame
within 14 months after percutaneous coronary stent implantation
Secondary Outcome Measure Information:
Title
coronary vasomotor function
Description
coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise
Time Frame
within 14 months after stentimplantation
Title
mean neointimal thickness assessed by OCT
Time Frame
within 14 months after stent implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Togni, MD
Phone
++41-26-426-8130
Email
mario.togni@unifr.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Cook, MD
Phone
++41-26-426-8130
Email
stephane.cook@unifr.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Togni, MD
Organizational Affiliation
University of Fribourg, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphane Cook, MD
Organizational Affiliation
University of Fribourg, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Stauffer, MD
Organizational Affiliation
Hopital Cantonal HFR, Fribourg, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Goy, MD
Organizational Affiliation
Hopital Cantonal HFR, Fribourg, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gérard Baeriswyl, MD
Organizational Affiliation
Hopital Cantonal HFR, Fribourg, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pieter C Smits, MD, PhD
Organizational Affiliation
Maasstad Ziekenhuis, Rotterdam, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cantonal HFR
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Schafroth, RN
Phone
++41-26-426-8507
Email
schrafrotho@h-fr.ch
First Name & Middle Initial & Last Name & Degree
Mario Togni, MD
12. IPD Sharing Statement
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COMPARE-II- Vasomotion and Imaging Substudy
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