Overview

This trial is active, not recruiting.

Condition acute coronary syndromes
Treatment oct
Sponsor Centre Hospitalier Universitaire de Besancon
Start date October 2012
End date October 2016
Trial size 230 participants
Trial identifier NCT01743274, P/2012/141

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
(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).
oct Optical coherence tomography
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 Outcomes

Measure
Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)
time frame: Measured at the end of the angioplasty procedure

Secondary Outcomes

Measure
Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty
time frame: 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
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)
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)
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
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)
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)
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)

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study
Principal investigator Nicolas F. Meneveau, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon.