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COMPARE-II- Vasomotion and Imaging Substudy (COMPARE-IT)

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ClinicalTrials.gov Identifier: NCT01329237
Recruitment Status : Unknown
Verified January 2011 by University of Freiburg.
Recruitment status was:  Recruiting
First Posted : April 5, 2011
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: dynamic physical exercise and OCT imaging Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : March 2011
Estimated Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
dynamic physical exercise OCT
dynamic physical exercise and optical coherence tomography imaging
Other: dynamic physical exercise and OCT imaging
supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent


Outcome Measures

Primary Outcome Measures :
  1. percentage of uncovered stent struts per lesion assessed by OCT [ Time Frame: within 14 months after percutaneous coronary stent implantation ]

Secondary Outcome Measures :
  1. coronary vasomotor function [ Time Frame: within 14 months after stentimplantation ]
    coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise

  2. mean neointimal thickness assessed by OCT [ Time Frame: within 14 months after stent implantation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329237


Contacts
Contact: Mario Togni, MD ++41-26-426-8130 mario.togni@unifr.ch
Contact: Stéphane Cook, MD ++41-26-426-8130 stephane.cook@unifr.ch

Locations
Switzerland
Hopital Cantonal HFR Recruiting
Fribourg, Switzerland, 1708
Contact: Olivier Schafroth, RN    ++41-26-426-8507    schrafrotho@h-fr.ch   
Principal Investigator: Mario Togni, MD         
Sponsors and Collaborators
University of Freiburg
Investigators
Principal Investigator: Mario Togni, MD University of Fribourg, Switzerland
Principal Investigator: Stéphane Cook, MD University of Fribourg, Switzerland
Study Chair: Jean-Christophe Stauffer, MD Hopital Cantonal HFR, Fribourg, Switzerland
Study Chair: Jean-Jacques Goy, MD Hopital Cantonal HFR, Fribourg, Switzerland
Study Chair: Gérard Baeriswyl, MD Hopital Cantonal HFR, Fribourg, Switzerland
Principal Investigator: Pieter C Smits, MD, PhD Maasstad Ziekenhuis, Rotterdam, The Netherlands
More Information

Responsible Party: TOGNI Mario/Professor of Medicine, University of Fribourg Medical Center
ClinicalTrials.gov Identifier: NCT01329237     History of Changes
Other Study ID Numbers: COMPARE-II-Imaging
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: January 2011

Keywords provided by University of Freiburg:
drug-eluting stent
coronary endothelial function
coronary imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases