Does Optical Coherence Tomography Optimise Results of Stenting (DOCTORS)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Acute Coronary Syndromes

Treatments: Procedure: OCT

Study type: Interventional

Funder types: Other

Identifiers

NCT01743274

P/2012/141

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control Group

No Intervention group

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.

Optical Coherence Tomography

Experimental group

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).

Treatment:

Procedure: OCT