Does Optical Coherence Tomography Optimise Results of Stenting

NCT01743274 | Completed

• 1 other identifier: P/2012/141
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Coronary Syndromes

Keywords

acute coronary syndromes; non-ST elevation myocardial infarction; angioplasty; fractional flow reserve; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at the end of the angioplasty procedure

Secondary Outcomes (7)

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

  Assessed during the initial angioplasty procedure (Day 0)

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

  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)

• Safety of OCT in the context of angioplasty for ACS

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

• Adverse cardiac events at 6 months

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

• 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.

  At the end of the initial angioplasty procedure (Day 0)

Study Arms (2)

Control Group

NO INTERVENTION

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.

Optical Coherence Tomography

EXPERIMENTAL

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

Interventions

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.

Also known as: Optical coherence tomography

Optical Coherence Tomography

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (8)

Annecy Hospital

Annecy, Metz-Tessy, 74370, France

Location

Centre Hospitalier

Belfort, 90000, France

Location

University Hospital Jean Minjoz

Besançon, 25000, France

Location

Centre Hospitalier de Chambery

Chambéry, 73000, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

Centre Hospitalier Universitaire Régional

Lille, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Related Publications (3)

• 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.

  PMID: 25066556 BACKGROUND

• 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.

  PMID: 27573032 RESULT

• 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.

  PMID: 28242645 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Nicolas F. Meneveau, MD

  University Hospital Besancon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: December 6, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

FR (8)