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NCT Number: NCT01743274

Does Optical Coherence Tomography Optimise Results of Stenting

Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Annecy Hospital, Annecy, Metz-Tessy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients aged 18 to 80 years inclusive, admitted for acute coronary syndrome (ACS) with the following symptoms :

  • Clinical signs of ischemia (chest pain) at rest lasting for at least 10 minutes in the previous 72 hours;
  • AND at least one of the following two criteria :
  • New ST segment depression ≥1 mm or transitory ST segment elevation (<30 minutes) (≥1 mm) on at least 2 contiguous leads of the ECG; OR
  • Elevation (>upper limit of normal, ULN) of cardiac enzymes (CK-MB, Troponin I or T).

AND Presenting an indication for coronary angioplasty with stent implantation of the target lesion considered to be responsible for the ACS.

AND Written informed consent.

Exclusion criteria

Potential subjects who meet any of the following criteria will be excluded from the study:

  • Left main stem disease
  • Presence of coronary artery bypass grafts
  • Cardiogenic shock or severe hemodynamic instability
  • Severely calcified or tortuous arteries
  • Persistent ST segment elevation
  • One or more other lesions considered angiographically significant and located on the target vessel
  • Severe renal insufficiency (creatinine clearance ≤30 mL/min)
  • Bacteraemia or septicaemia
  • Severe coagulation disorders
  • Patients who refuse to sign the informed consent form

Treatment and study plan

OCT

Procedure

Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting.

OCT images are acquired by automated pullback over 2 to 3 seconds of the light source that yields a helicoidal image of a longitudinal segment of 50 mm. Intravascular imaging is obtained by injecting contrast medium or saline solution.

Other names: Optical coherence tomography

Primary outcomes

  1. Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)

    Time frame: Measured at the end of the angioplasty procedure

    Evaluation of the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) at the end of the procedure.

    The average of three consecutive FFR measures will be recorded.

Secondary outcomes

  1. Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty

    Time frame: Assessed during the initial angioplasty procedure (Day 0)

    Assessed by the presence of any one or more of the following criteria:

    Incomplete coverage of the lesion by the stent, Residual stenosis upstream or downstream from the stent, Edge dissection, Presence of thrombus, Tissue protrusion through the stent struts, Stent Malapposition.

  2. Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images

    Time frame: During the initial angioplasty procedure, as soon as the operator decides whether or not to proceed with additional interventions based on OCT data (Day 0)

    Any one or more of the following criteria based on the information obtained from OCT images:

    Diameter and length of implanted stents Supplementary balloon inflations Implantation of supplementary stent(s) Use of glycoprotein (GP) IIb/IIIa inhibitors Use of thrombo-aspiration Use of rotational atherectomy

  3. Safety of OCT in the context of angioplasty for ACS

    Time frame: At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)

    Safety as assessed by the following criteria:

    • Duration of the procedure
    • Fluoroscopy time
    • Quantity of contrast medium used
    • Procedural complications (no reflow, coronary perforation, occlusive dissection, spasm, stent occlusion, troponin peak at 24 hours, creatinine clearance at 24 hours)

  4. Adverse cardiac events at 6 months

    Time frame: Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty

    Any one or more of the following:

    • Death
    • Recurrent MI
    • Stent thrombosis
    • Repeat revascularisation of the target vessel

  5. Determination of a threshold value for quantitative OCT measures (i.e. minimal lumen diameter and minimal lumen area) that best predict a fractional flow reserve value >=0.90.

    Time frame: At the end of the initial angioplasty procedure (Day 0)

    Determination of a threshold value for quantitative OCT measures (i.e. minimal lumen diameter and minimal lumen area) that best predict a fractional flow reserve (FFR) value >=0.90.

  6. Identification of quantitative OCT (i.e. minimum lumen diameter and minimum lumen area) variables that predict FFR as measured at the end of the initial angioplasty procedure.

    Time frame: At the end of the initial angioplasty procedure (Day 0)

    Identification of quantitative OCT (i.e. minimum lumen diameter and minimum lumen area) variables that predict the value of fractional flow reserve as measured at the end of the initial angioplasty procedure on day 0.

  7. Comparison between online and offline analyses of OCT data

    Time frame: Analysis of offline data is performed centrally, and comparison will be performed once both online and offline analysis data are performed (Day 90)

    Comparison between results of online and offline analyses of OCT data.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

Acronym: DOCTORS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 6, 2012
Registry last updated
Nov 21, 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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