Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2011-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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dynamic physical exercise OCT
dynamic physical exercise and optical coherence tomography imaging
dynamic physical exercise and OCT imaging
supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent
Interventions
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dynamic physical exercise and OCT imaging
supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent
Eligibility Criteria
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Inclusion Criteria
* Patient consent to undergo a non-scheduled follow- up angiography with imaging study and bicycle exercise testing
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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University of Freiburg
OTHER
Responsible Party
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University of Fribourg Medical Center
Principal Investigators
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Mario Togni, MD
Role: PRINCIPAL_INVESTIGATOR
University of Fribourg, Switzerland
Stéphane Cook, MD
Role: PRINCIPAL_INVESTIGATOR
University of Fribourg, Switzerland
Jean-Christophe Stauffer, MD
Role: STUDY_CHAIR
Hopital Cantonal HFR, Fribourg, Switzerland
Jean-Jacques Goy, MD
Role: STUDY_CHAIR
Hopital Cantonal HFR, Fribourg, Switzerland
Gérard Baeriswyl, MD
Role: STUDY_CHAIR
Hopital Cantonal HFR, Fribourg, Switzerland
Pieter C Smits, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maasstad Ziekenhuis, Rotterdam, The Netherlands
Locations
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Hopital Cantonal HFR
Fribourg, Canton of Fribourg, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COMPARE-II-Imaging
Identifier Type: -
Identifier Source: org_study_id
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