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Trial record 1 of 1 for:    NCT02337348
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Prospective Randomized Optical Coherence Tomography Oslo tRial (PROCTOR)

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ClinicalTrials.gov Identifier: NCT02337348
Recruitment Status : Terminated (Stopped due to slow inclusion)
First Posted : January 13, 2015
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eigil Fossum, 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Angina Other: Optical coherence tomography Radiation: Coronary angiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography (OCT) Guided Compared to Conventional Angiography Guided Coronary Intervention in Stentfailure
Study Start Date : August 2014
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: OCT guided coronary intervention
Coronary angiography and optical coherence tomography imaging
Other: Optical coherence tomography
Preintervention imaging
Other Name: OCT

Radiation: Coronary angiography
Conventional coronary intervention

Active Comparator: Conventional coronary intervention
Coronary angiography
Radiation: Coronary angiography
Conventional coronary intervention




Primary Outcome Measures :
  1. Target lesion revascularisation [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. non-fatal myocardial infarction [ Time Frame: 5 years ]
  2. Cardiovascular mortality [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Change in kidney function [ Time Frame: 5 years ]
    Number of participants with more than 25% increase in serum creatinin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337348


Locations
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Norway
Oslo university hospital
Oslo, Norway, 0447
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Chair: Eigil Fossum, MD Oslo University Hospital
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Responsible Party: Eigil Fossum, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02337348    
Other Study ID Numbers: 2013/1653/REK
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Keywords provided by Eigil Fossum, Oslo University Hospital:
coronary stents
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases