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Does Optical Coherence Tomography Optimise Results of Stenting (DOCTORS)

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OCT
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring acute coronary syndromes, non-ST elevation myocardial infarction, angioplasty, fractional flow reserve, optical coherence tomography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Annecy Hospital
  • Centre Hospitalier
  • University Hospital Jean Minjoz
  • Centre Hospitalier de Chambery
  • Hôpital Gabriel Montpied
  • Centre Hospitalier Universitaire Régional
  • Institut Mutualiste Montsouris
  • Nouvel Hôpital Civil

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Optical Coherence Tomography

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)
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 Outcome Measures

Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty
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
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
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
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.
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.
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
Comparison between results of online and offline analyses of OCT data.

Full Information

First Posted
November 23, 2012
Last Updated
November 20, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT01743274
Brief Title
Does Optical Coherence Tomography Optimise Results of Stenting
Acronym
DOCTORS
Official Title
Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
acute coronary syndromes, non-ST elevation myocardial infarction, angioplasty, fractional flow reserve, optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Optical Coherence Tomography
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
OCT
Other Intervention Name(s)
Optical coherence tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)
Description
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.
Time Frame
Measured at the end of the angioplasty procedure
Secondary Outcome Measure Information:
Title
Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty
Description
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.
Time Frame
Assessed during the initial angioplasty procedure (Day 0)
Title
Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images
Description
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
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)
Title
Safety of OCT in the context of angioplasty for ACS
Description
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)
Time Frame
At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)
Title
Adverse cardiac events at 6 months
Description
Any one or more of the following: Death Recurrent MI Stent thrombosis Repeat revascularisation of the target vessel
Time Frame
Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty
Title
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.
Description
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.
Time Frame
At the end of the initial angioplasty procedure (Day 0)
Title
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.
Description
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.
Time Frame
At the end of the initial angioplasty procedure (Day 0)
Title
Comparison between online and offline analyses of OCT data
Description
Comparison between results of 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas F. Meneveau, MD
Organizational Affiliation
University Hospital Besancon, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annecy Hospital
City
Annecy
State/Province
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
Centre Hospitalier
City
Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
University Hospital Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Centre Hospitalier de Chambery
City
Chambéry
ZIP/Postal Code
73000
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont Ferrand
Country
France
Facility Name
Centre Hospitalier Universitaire Régional
City
Lille
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Facility Name
Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25066556
Citation
Meneveau N, Ecarnot F, Souteyrand G, Motreff P, Caussin C, Van Belle E, Ohlmann P, Morel O, Grentzinger A, Angioi M, Chopard R, Schiele F. Does optical coherence tomography optimize results of stenting? Rationale and study design. Am Heart J. 2014 Aug;168(2):175-81.e1-2. doi: 10.1016/j.ahj.2014.05.007. Epub 2014 May 24.
Results Reference
background
PubMed Identifier
27573032
Citation
Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.
Results Reference
result
PubMed Identifier
28242645
Citation
Meneveau N, Ecarnot F. Response by Meneveau and Ecarnot to Letter Regarding Article, "Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting)". Circulation. 2017 Feb 28;135(9):e142-e143. doi: 10.1161/CIRCULATIONAHA.116.026277. No abstract available.
Results Reference
result

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