Prospective Randomized Optical Coherence Tomography Oslo tRial

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-01-31

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.

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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.

Conditions

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Myocardial Infarction Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OCT guided coronary intervention

Coronary angiography and optical coherence tomography imaging

Group Type EXPERIMENTAL

Optical coherence tomography

Intervention Type OTHER

Preintervention imaging

Coronary angiography

Intervention Type RADIATION

Conventional coronary intervention

Coronary angiography

Group Type ACTIVE_COMPARATOR

Coronary angiography

Intervention Type RADIATION

Conventional coronary intervention

Interventions

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Optical coherence tomography

Preintervention imaging

Intervention Type OTHER

Coronary angiography

Conventional coronary intervention

Intervention Type RADIATION

Other Intervention Names

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OCT

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No