Prospective Randomized Optical Coherence Tomography Oslo tRial (PROCTOR)
Primary Purpose
Myocardial Infarction, Angina
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Optical coherence tomography
Coronary angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction focused on measuring coronary stents
Eligibility Criteria
Inclusion Criteria:
Clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome.
Exclusion Criteria:
- Patient not able to give informed consent.
- Unwillingness.
- Life expectancy < 5 years.
- Reduced kidney function with GRF<45.
- Coronary artery diameter < 2.5mm.
- Pregnancy.
- Patients without 11-digit Norwegian personal number.
Sites / Locations
- Oslo university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OCT guided coronary intervention
Conventional coronary intervention
Arm Description
Coronary angiography and optical coherence tomography imaging
Coronary angiography
Outcomes
Primary Outcome Measures
Target lesion revascularisation
Secondary Outcome Measures
non-fatal myocardial infarction
Cardiovascular mortality
Full Information
NCT ID
NCT02337348
First Posted
December 23, 2014
Last Updated
August 29, 2019
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02337348
Brief Title
Prospective Randomized Optical Coherence Tomography Oslo tRial
Acronym
PROCTOR
Official Title
Optical Coherence Tomography (OCT) Guided Compared to Conventional Angiography Guided Coronary Intervention in Stentfailure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to slow inclusion
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Coronary artery intervention with stents is a routine procedure with several clinical indications. A stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some patients. Several different mechanisms have been suggested. Stentfailure may be caused by mechanical properties of the stent. This may be secondary to suboptimal stentimplantation, ie over/undersizing or acquired ie malapposition or stentfracture. These stentproperties may be difficult to identify with conventional coronary angiography due to low image resolution. The hypothesis of the study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment with a subsequent reduction in later stentfailure.
Detailed Description
The hypothesis of the PROCTOR study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment in stent failure. However, the prevalence of stentfailure (ie stent malapposition, stentfracture, stentedgedissections etc) not causing clinical endpoints is not known. In a subset of patients (n=100) with previously implanted stents performing a new coronary angiography based on clinical indication, functional or patent stents (decided by Heart team) will be characterized with OCT and the patients followed for 5 years. The purpose of this substudy, OCT IPS (OCT In Patent Stents), is to estimate the prevalence of stentpathology in patent or functional stents and compare findings with the active arm of PROCTOR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angina
Keywords
coronary stents
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCT guided coronary intervention
Arm Type
Experimental
Arm Description
Coronary angiography and optical coherence tomography imaging
Arm Title
Conventional coronary intervention
Arm Type
Active Comparator
Arm Description
Coronary angiography
Intervention Type
Other
Intervention Name(s)
Optical coherence tomography
Other Intervention Name(s)
OCT
Intervention Description
Preintervention imaging
Intervention Type
Radiation
Intervention Name(s)
Coronary angiography
Intervention Description
Conventional coronary intervention
Primary Outcome Measure Information:
Title
Target lesion revascularisation
Time Frame
5 years
Secondary Outcome Measure Information:
Title
non-fatal myocardial infarction
Time Frame
5 years
Title
Cardiovascular mortality
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Change in kidney function
Description
Number of participants with more than 25% increase in serum creatinin.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome.
Exclusion Criteria:
Patient not able to give informed consent.
Unwillingness.
Life expectancy < 5 years.
Reduced kidney function with GRF<45.
Coronary artery diameter < 2.5mm.
Pregnancy.
Patients without 11-digit Norwegian personal number.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eigil Fossum, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo university hospital
City
Oslo
ZIP/Postal Code
0447
Country
Norway
12. IPD Sharing Statement
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Prospective Randomized Optical Coherence Tomography Oslo tRial
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