NCT02337348

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

4.5 years

First QC Date

December 23, 2014

Last Update Submit

August 29, 2019

Conditions

Myocardial InfarctionAngina

Keywords

coronary stents

Outcome Measures

Primary Outcomes (1)

  • Target lesion revascularisation

    5 years

Secondary Outcomes (2)

  • non-fatal myocardial infarction

    5 years

  • Cardiovascular mortality

    5 years

Other Outcomes (1)

  • Change in kidney function

    5 years

Study Arms (2)

OCT guided coronary intervention

EXPERIMENTAL

Coronary angiography and optical coherence tomography imaging

Other: Optical coherence tomographyRadiation: Coronary angiography

Conventional coronary intervention

ACTIVE COMPARATOR

Coronary angiography

Radiation: Coronary angiography

Interventions

Optical coherence tomographyOTHER

Preintervention imaging

Also known as: OCT
OCT guided coronary intervention
Coronary angiographyRADIATION

Conventional coronary intervention

Conventional coronary interventionOCT guided coronary intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital

Oslo, 0447, Norway

Location

MeSH Terms

Conditions

Myocardial InfarctionAngina Pectoris

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Eigil Fossum, MD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 23, 2014

First Posted

January 13, 2015

Study Start

August 1, 2014

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

NO(1)