Prospective Randomized Optical Coherence Tomography Oslo tRial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optical Coherence Tomography (OCT) Guided Compared to Conventional Angiography Guided Coronary Intervention in Stentfailure

Conditions
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Myocardial Infarction, Angina

Intervention / Treatment
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* Other: Optical coherence tomography
* Radiation: Coronary angiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT guided coronary intervention<br>Coronary angiography and optical coherence tomography imaging | Other: Optical coherence tomography<br>* Preintervention imaging<br>* Other names: OCT;Radiation: Coronary angiography<br>* Conventional coronary intervention<br>|
| Active Comparator: Conventional coronary intervention<br>Coronary angiography | Radiation: Coronary angiography<br>* Conventional coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularisation |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-fatal myocardial infarction |  | 5 years | 
| Cardiovascular mortality |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary stents