Prospective Randomized Optical Coherence Tomography Oslo... | NCT02337348

Studies
Prospective Randomized Optical Coherence Tomography Oslo tRial

NCT02337348

Sponsor

Oslo University Hospital

Status

Terminated

Last Update Posted

Sep 3, 2019Actual

Enrollment

163Actual

Phase

Not Applicable

Conditions

Myocardial Infarction
Angina

Interventions

Optical coherence tomography
Coronary angiography

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped due to slow inclusion

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Dec 23, 2014

First Submission Date that Met QC Criteria

Jan 8, 2015

First Posted Date

Jan 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2019

Last Update Posted Date

Sep 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eigil Fossum, MD, PhD, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCT guided coronary intervention	Experimental	Coronary angiography and optical coherence tomography imaging	Other: Optical coherence tomography Radiation: Coronary angiography
Conventional coronary intervention	Active Comparator	Coronary angiography	Radiation: Coronary angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical coherence tomography	Other	Preintervention imaging	OCT guided coronary intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Target lesion revascularisation		5 years

Secondary Outcomes

Measure	Description	Time Frame
non-fatal myocardial infarction		5 years
Cardiovascular mortality		5 years

Other Outcomes

Measure	Description	Time Frame
Change in kidney function	Number of participants with more than 25% increase in serum creatinin.	5 years

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eigil Fossum, MD	Oslo University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo university hospital		Oslo		0447	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D000787	Angina Pectoris

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided