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

Aarhus University Hospital Skejby

Status: Completed

Conditions: Myocardial Infarction; Coronary Disease; Atherosclerosis

Treatments: Procedure: Comparison of OCT scans; Procedure: Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare

Study type: Observational

Funder types: Other

Identifiers

NCT02237456

1-10-72-59-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)