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Does Optical Coherence Tomography Optimise Results of Stenting (DOCTORS)

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ClinicalTrials.gov Identifier: NCT01743274
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date  ICMJE November 23, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date November 21, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
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 two consecutive FFR measures will be recorded.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • 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.
  • 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
  • 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)
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • 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, Residual dissection, Presence of thrombus, Tissue protrusion through the stent struts, Stent Malapposition.
  • 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
  • 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)
  • 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
    • Any bleeding event (as classified by the Bleeding Academic Research Consortium (BARC) criteria)
    • Repeat revascularisation of the target vessel
  • Correlation between quantitative measures by OCT (i.e. minimal lumen diameter and minimal lumen area) and fractional flow reserve. [ Time Frame: At the end of the initial angioplasty procedure (Day 0) ]
    Correlation between quantitative measures by OCT (i.e. minimal lumen diameter and minimal lumen area) and fractional flow reserve values obtained with the pressure wire at the end of the procedure.
  • 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 <=0.75. [ 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 <=0.75, which is the widely accepted FFR threshold for hemodynamically significant stenosis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Optical Coherence Tomography Optimise Results of Stenting
Official Title  ICMJE Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE Procedure: OCT

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 Name: Optical coherence tomography
Study Arms  ICMJE
  • No Intervention: Control Group

    Randomization will be performed after initial coronary angiography, once the operator has identified the lesion responsible for the ACS. Patients will be randomly allocated to one of two groups. In the "Control" Group, the angioplasty procedure will be guided by traditional fluoroscopy alone.

    In both groups, fractional flow reserve (FFR) will be measured at the end of the procedure, once the operator considers the result of the angioplasty to be optimal. The average of three consecutive FFR measures will be recorded.

  • Experimental: Optical Coherence Tomography

    Randomization will be performed after initial coronary angiography, once the operator has identified the lesion responsible for the ACS. Patients will be randomly allocated to one of two groups.

    In the "OCT" group, OCT will be performed to optimise the results of angioplasty. The procedure will be performed according to usual practice, with or without pre-dilation before implantation of one or more stents (drug-eluting or bare metal). In the OCT group, OCT will be performed after initial coronary angiography and at the end of the procedure and the operator will have the possibility to change procedural strategy according to the data immediately available on the OCT images, with the possibility of additional interventions (additional balloon inflations, addition stent implantation, use of GPIIb/IIIa inhibitors and/or thromboaspiration and/or rotational atherectomy).

    Intervention: Procedure: OCT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)
240
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
230
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743274
Other Study ID Numbers  ICMJE P/2012/141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Hospitalier Universitaire de Besancon
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicolas F. Meneveau, MD University Hospital Besancon, France
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP