DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"

Myocardial Infarction Clinical Trial

Official title:

Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237456
• Other study ID #: 1-10-72-59-14
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: March 12, 2015
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to compare optical coherence tomography (OCT) scans performed in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after implantation of stents or bioresorbable scaffolds.

Description:

Standard treatment of persons with narrowings of the heart's coronary artery is balloon treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with contrast is used. X-ray fluoroscopy produces little information of any disease changes in the vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable scaffolds are visualized poorly .

Optical coherence tomography (OCT) is a light-based, high resolution, imaging modality for intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave, Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two systems are similar and are interpreted the same way.

The aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with same characteristics by the two systems.

Same segment scans by the two systems will be systematically compared and reported.

Differences in scans by the two systems may have implications for the interpretation and thus may affect clinical decisions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for intervention with PCI on the right or left coronary artery

• Age >18 years

• Must be able to give written informed consent

Exclusion Criteria:

• Expected life span of less than one year

• Pregnancy or possible pregnancy

• Cardiogenic shock

• Especially tortuous vessels

• Renal impairment (creatinine> 100 micromoles / L)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Comparison of OCT scans

• Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N, Denmark
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images		Baseline	Yes
Primary	Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)		Baseline	Yes
Primary	Characteristics of fibrous tissue (maximum scan penetrance)		Baseline	Yes
Primary	Characteristics of lipid plaque (signal intensities under the fibrous cap)		Baseline	Yes
Primary	Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)		Baseline	Yes
Primary	Characteristics of vessel dissection (exploratory)		Baseline	Yes
Primary	Characteristics of the fibrous cap (minimum thickness)		Baseline	Yes
Secondary	Detection of stent struts	Stent evaluation obtained by Lunawawe recordings versus OPTIS recordings (including areas with thrombus, plaque, bare metal stent, bioresorbable stents, 3D reconstruction of stents (qualitative and quantitative assessment of stent visualization degree)	Baseline	Yes