Skip to content

Prospective Randomized Optical Coherence Tomography Oslo tRial

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02337348
Acronym
PROCTOR
Enrollment
163
Registered
2015-01-13
Start date
2014-08-31
Completion date
2019-01-31
Last updated
2019-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina, Myocardial Infarction

Keywords

coronary stents

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.

Interventions

OTHEROptical coherence tomography

Preintervention imaging

RADIATIONCoronary angiography

Conventional coronary intervention

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Target lesion revascularisation5 years

Secondary

MeasureTime frame
non-fatal myocardial infarction5 years
Cardiovascular mortality5 years

Other

MeasureTime frameDescription
Change in kidney function5 yearsNumber of participants with more than 25% increase in serum creatinin.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026