Prospective Randomized Optical Coherence Tomography Oslo tRial

Not Applicable

Terminated

• Conditions: Angina; Myocardial Infarction
• Interventions: Other: Optical coherence tomography; Radiation: Coronary angiography

• Registration Number: NCT02337348
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 163

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCT guided coronary intervention	Optical coherence tomography	Coronary angiography and optical coherence tomography imaging
OCT guided coronary intervention	Coronary angiography	Coronary angiography and optical coherence tomography imaging
Conventional coronary intervention	Coronary angiography	Coronary angiography

Primary Outcome Measures

Name	Time	Method
Target lesion revascularisation	5 years

Secondary Outcome Measures

Name	Time	Method
non-fatal myocardial infarction	5 years
Cardiovascular mortality	5 years

Trial Locations

Locations (1)

Oslo university hospital; 🇳🇴 Oslo, Norway