Does Optical Coherence Tomography Optimise Results of Stenting (DOCTORS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01743274
First received: November 23, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndromes
Procedure: OCT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) [ Time Frame: Measured at the end of the angioplasty procedure ] [ Designated as safety issue: No ]

    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 [ Time Frame: Assessed during the initial angioplasty procedure (Day 0) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Comparison between results of online and offline analyses of OCT data.


Estimated Enrollment: 230
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743274

Contacts
Contact: Nicolas F. Meneveau, MD 33381668624 nicolas.meneveau@univ-fcomte.fr
Contact: Fiona Ecarnot, MSc 33381668539 fiona.ecarnot@univ-fcomte.fr

Locations
France
Centre Hospitalier Recruiting
Belfort, France, 90000
Contact: Alain Grentzinger, MD       agrentzinger@chbm.fr   
Principal Investigator: Alain Grentzinger, MD         
University Hospital Jean Minjoz Recruiting
Besancon, France, 25000
Contact: Nicolas F. Meneveau, MD    33381668624    nicolas.meneveau@univ-fcomte.fr   
Contact: Fiona Ecarnot, MSc    33381668539    fiona.ecarnot@univ-fcomte.fr   
Sub-Investigator: Francois Schiele, MD         
Sub-Investigator: Romain Chopard, MD         
Sub-Investigator: Marie-France Seronde, MD         
Sub-Investigator: Sebastien Janin, MD         
Sub-Investigator: Philoktimon Plastaras, MD         
Centre Hospitalier de Chambery Not yet recruiting
Chambéry, France, 73000
Contact: Vincent Descotes-Genon, MD    33479965850      
Principal Investigator: Vincent Descotes-Genon, MD         
Hôpital Gabriel Montpied Recruiting
Clermont Ferrand, France
Contact: Pascal Motreff, MD    33473751410    pmotreff@chu-clermontferrand.fr   
Principal Investigator: Pascal Motreff, MD         
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis Robinson, France
Contact: Christophe Caussin, MD       caussin@ccml.fr   
Principal Investigator: Christophe Caussin, MD         
Centre Hospitalier Universitaire Régional Recruiting
Lille, France
Contact: Eric Van Belle, MD       ericvanbelle@aol.com   
Principal Investigator: Eric Van Belle, MD         
Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67000
Contact: Patrick Ohlmann, MD    33369550589    patrick.ohlmann@chru-strasbourg.fr   
Sub-Investigator: Olivier Morel, MD         
Principal Investigator: Patrick Ohlmann, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Nicolas F. Meneveau, MD University Hospital Besancon, France
  More Information

No publications provided by Centre Hospitalier Universitaire de Besancon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01743274     History of Changes
Other Study ID Numbers: P/2012/141
Study First Received: November 23, 2012
Last Updated: December 3, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Besancon:
acute coronary syndromes
non-ST elevation myocardial infarction
angioplasty
fractional flow reserve
optical coherence tomography

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014