Prospective Randomized Optical Coherence Tomography Oslo tRial (PROCTOR)

University of Oslo (UIO)

Status: Terminated

Conditions: Myocardial Infarction; Angina

Treatments: Other: Optical coherence tomography; Radiation: Coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02337348

2013/1653/REK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

OCT guided coronary intervention

Experimental group

Description:

Coronary angiography and optical coherence tomography imaging

Treatment:

Other: Optical coherence tomography

Radiation: Coronary angiography

Conventional coronary intervention

Active Comparator group

Description:

Coronary angiography

Treatment:

Radiation: Coronary angiography