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OpenTrials
Completed

NCT Number: NCT02919943

Observational Study of Angiographic Coregistered Optical Coherence Tomography in Patients Undergoing PCI

To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Patient provides signed written informed consent before any study-specific procedure.
  • Patients suffer from coronary artery disease (CAD) including at least one angiographically significant (>70% visual estimation) stenosis present in a native coronary artery with planned PCI.

Exclusion criteria

  • Subjects with emergent PCI or in cardiogenic shock.
  • Subjects with target left main (LM) lesion, with restenosis or stent thrombosis in the target vessel or with aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
  • Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion.
  • Known renal insufficiency (examples being but not limited to estimated glomerular Filtration rate (eGFR) < 50 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL or on dialysis).
  • Any other medical condition that in the opinion of the investigator will interfere with patients safety or study results.
  • Currently participating in another clinical study that interferes with study results.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
  • Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy

Treatment and study plan

Percutaneous coronary intervention

Procedure

OCT-guided Percutaneous Coronary Intervention.

Primary outcomes

  1. The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone

    Time frame: 20 months

Secondary outcomes

  1. Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment.

    Time frame: 30 days, 6 months, and 12 months.

  2. Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone.

    Time frame: 20 months

  3. Longitudinal geographical miss (GM) with uncovered residual parts of "target lesion" at the proximal or distal reference segment of the stent. Detected by comparison between pre-PCI OCT with post-PCI OCT.

    Time frame: 20 months

  4. Rate of side branch occlusions (%).

    Time frame: 20 months

  5. Strategy changes based on post-procedural OCT and ACR Imaging.

    Time frame: 20 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Impact of Angiographic Coregistered Optical Coherence Tomography-diagnostics on Physicians Decision-making During Percutaneous Coronary Intervention in Patients With Advanced Coronary Artery Disease - the "OPTICO-Integration-Trial"

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2016
Registry last updated
May 16, 2017

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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