Prospective Randomized Optical Coherence Tomography Oslo tRial

Myocardial Infarction Clinical Trial

— PROCTOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02337348
• Other study ID #: 2013/1653/REK
• Status: Terminated
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 163
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina
• Infarction
• Myocardial Infarction

Intervention

Other:
• Optical coherence tomography
Preintervention imaging

Radiation:
• Coronary angiography
Conventional coronary intervention

Locations

Country	Name	City	State
Norway	Oslo university hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in kidney function	Number of participants with more than 25% increase in serum creatinin.	5 years
Primary	Target lesion revascularisation		5 years
Secondary	non-fatal myocardial infarction		5 years
Secondary	Cardiovascular mortality		5 years