Does Optical Coherence Tomography Optimise Results of Stenting

Acute Coronary Syndromes Clinical Trial

— DOCTORS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743274
• Other study ID #: P/2012/141
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: November 20, 2017
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

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.

Locations

Country	Name	City	State
France	Annecy Hospital	Annecy	Metz-Tessy
France	Centre Hospitalier	Belfort
France	University Hospital Jean Minjoz	Besancon
France	Centre Hospitalier de Chambery	Chambéry
France	Hôpital Gabriel Montpied	Clermont Ferrand
France	Centre Hospitalier Universitaire Régional	Lille
France	Institut Mutualiste Montsouris	Paris
France	Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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 Multicen — View Citation

Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrançois 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty	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.	Assessed during the initial angioplasty procedure (Day 0)
Secondary	Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images	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	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)
Secondary	Safety of OCT in the context of angioplasty for ACS	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)	At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)
Secondary	Adverse cardiac events at 6 months	Any one or more of the following: Death; Recurrent MI; Stent thrombosis; Repeat revascularisation of the target vessel	Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty
Secondary	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.	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.	At the end of the initial angioplasty procedure (Day 0)
Secondary	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.	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.	At the end of the initial angioplasty procedure (Day 0)
Secondary	Comparison between online and offline analyses of OCT data	Comparison between results of 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)