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Completed

NCT Number: NCT02237456

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus N, Denmark, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comparison of OCT scans

Procedure

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

Procedure

Primary outcomes

  1. Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images

    Time frame: Baseline

  2. Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)

    Time frame: Baseline

  3. Characteristics of fibrous tissue (maximum scan penetrance)

    Time frame: Baseline

  4. Characteristics of lipid plaque (signal intensities under the fibrous cap)

    Time frame: Baseline

  5. Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)

    Time frame: Baseline

  6. Characteristics of vessel dissection (exploratory)

    Time frame: Baseline

  7. Characteristics of the fibrous cap (minimum thickness)

    Time frame: Baseline

Secondary outcomes

  1. Detection of stent struts

    Time frame: Baseline

    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)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2014
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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