Clinical trial NCT02337348: Prospective Randomized Optical Coherence Tomography Oslo tRial
Official title: Optical Coherence Tomography (OCT) Guided Compared to Conventional Angiography Guided Coronary Intervention in Stentfailure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction
Angina
Keywords: coronary stents
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Target lesion revascularisation
timeFrame: 5 years
Secondary outcomes:
measure: non-fatal myocardial infarction
timeFrame: 5 years
measure: Cardiovascular mortality
timeFrame: 5 years
Other outcomes:
measure: Change in kidney function
timeFrame: 5 years
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
Study officials:
affiliation: Oslo University Hospital
name: Eigil Fossum, MD
role: STUDY_CHAIR
References: