Coronary Artery DiseasePhase 4COMPARE-ITNCT01329237
COMPARE-II- Vasomotion and Imaging Substudy
A Phase 4 study testing dynamic physical exercise and OCT imaging in people with Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- dynamic physical exercise and OCT imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Hopital Cantonal HFR
Fribourg, Canton of Fribourg, 1708
Olivier Schafroth, RN, ++41-26-426-8507, schrafrotho@h-fr.ch
Mario Togni, MD
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- dynamic physical exercise and OCT imaging
- Keywords
- drug-eluting stent, coronary endothelial function, coronary imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic physical exercise and OCT imagingOther
supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent
| Study group | Role | What they receive |
|---|---|---|
| dynamic physical exercise OCT | Other | dynamic physical exercise and optical coherence tomography imaging Receives: Other: dynamic physical exercise and OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of uncovered stent struts per lesion assessed by OCT
Measured: within 14 months after percutaneous coronary stent implantation
Secondary outcomes (2)
coronary vasomotor function
coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise
Measured: within 14 months after stentimplantation
mean neointimal thickness assessed by OCT
Measured: within 14 months after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Mario Togni, MD, Principal investigator, University of Fribourg, SwitzerlandStéphane Cook, MD, Principal investigator, University of Fribourg, SwitzerlandJean-Christophe Stauffer, MD, Study chair, Hopital Cantonal HFR, Fribourg, SwitzerlandJean-Jacques Goy, MD, Study chair, Hopital Cantonal HFR, Fribourg, SwitzerlandGérard Baeriswyl, MD, Study chair, Hopital Cantonal HFR, Fribourg, SwitzerlandPieter C Smits, MD, PhD, Principal investigator, Maasstad Ziekenhuis, Rotterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329237
- Sponsor's protocol ID
- COMPARE-II-Imaging
- Acronym
- COMPARE-IT
- Status last verified
- Jan 2011
- First submitted
- 28 Mar 2011
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01329237
- Acronym / sponsor ID
- COMPARE-IT / COMPARE-II-Imaging
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting stent, coronary endothelial function, coronary imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (estimated)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dynamic physical exercise OCT | Other | Other: dynamic physical exercise and OCT imagingdynamic physical exercise and optical coherence tomography imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic physical exercise and OCT imagingsupine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent | Other | dynamic physical exercise OCT |
Primary outcome
percentage of uncovered stent struts per lesion assessed by OCT
Time frame: within 14 months after percutaneous coronary stent implantation
2 secondary outcomes
coronary vasomotor function
Time frame: within 14 months after stentimplantation
mean neointimal thickness assessed by OCT
Time frame: within 14 months after stent implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Togni, MD principal investigator
University of Fribourg, Switzerland
Stéphane Cook, MD principal investigator
University of Fribourg, Switzerland
Jean-Christophe Stauffer, MD study chair
Hopital Cantonal HFR, Fribourg, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dynamic physical exercise and OCT imaging in people with Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Togni, MD (++41-26-426-8130, mario.togni@unifr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of uncovered stent struts per lesion assessed by OCT (time frame: within 14 months after percutaneous coronary stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.