DOCTORS: Does Optical Coherence Tomography Optimise Results of Stenting

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT01743274

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndromes	Procedure: OCT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Optical coherence tomography

Arm

Intervention/Treatment

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 Names:

Optical coherence tomography

Outcome Measures

Primary Outcome Measures

Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) [Measured at the end of the angioplasty procedure]
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 during the initial angioplasty procedure (Day 0)]
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 [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)]
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 [At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)]
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 [Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty]
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. [At the end of the initial angioplasty procedure (Day 0)]
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. [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 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 [Analysis of offline data is performed centrally, and comparison will be performed once both online and offline analysis data are performed (Day 90)]
Comparison between results of online and offline analyses of OCT data.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Annecy Hospital	Annecy	Metz-Tessy	France	74370
2	Centre Hospitalier	Belfort		France	90000
3	University Hospital Jean Minjoz	Besancon		France	25000
4	Centre Hospitalier de Chambery	Chambéry		France	73000
5	Hôpital Gabriel Montpied	Clermont Ferrand		France
6	Centre Hospitalier Universitaire Régional	Lille		France
7	Institut Mutualiste Montsouris	Paris		France
8	Nouvel Hôpital Civil	Strasbourg		France	67000