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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Disease Myocardial Infarction Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Comparison of OCT scans

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No