Does Optical Coherence Tomography Optimise Results of Stenting (DOCTORS)
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Purpose
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 | Intervention |
|---|---|
|
Acute Coronary Syndromes |
Procedure: OCT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study |
- Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) [ Time Frame: Measured at the end of the angioplasty procedure ] [ Designated as safety issue: No ]
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 two consecutive FFR measures will be recorded.
- Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty [ Time Frame: Assessed during the initial angioplasty procedure (Day 0) ] [ Designated as safety issue: No ]
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, Residual 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 [ 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) ] [ Designated as safety issue: No ]
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 [ Time Frame: At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty ] [ Designated as safety issue: No ]
Any one or more of the following:
- Death
- Recurrent MI
- Stent thrombosis
- Any bleeding event (as classified by the Bleeding Academic Research Consortium (BARC) criteria)
- Repeat revascularisation of the target vessel
- Correlation between quantitative measures by OCT (i.e. minimal lumen diameter and minimal lumen area) and fractional flow reserve. [ Time Frame: At the end of the initial angioplasty procedure (Day 0) ] [ Designated as safety issue: No ]Correlation between quantitative measures by OCT (i.e. minimal lumen diameter and minimal lumen area) and fractional flow reserve values obtained with the pressure wire at the end of the procedure.
- 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 <=0.75. [ Time Frame: At the end of the initial angioplasty procedure (Day 0) ] [ Designated as safety issue: No ]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 <=0.75, which is the widely accepted FFR threshold for hemodynamically significant stenosis.
- Identification of OCT 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) ] [ Designated as safety issue: No ]Identification of the OCT variables that predict the value of fractional flow reserve as measured at the end of the initial angioplasty procedure on day 0.
| Estimated Enrollment: | 230 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 two 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. 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 two consecutive FFR measures will be recorded. |
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 Name: Optical coherence tomography
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Nicolas F. Meneveau, MD | 33381668624 | nicolas.meneveau@univ-fcomte.fr |
| Contact: Fiona Ecarnot, MSc | 33381668539 | fiona.ecarnot@univ-fcomte.fr |
| France | |
| Centre Hospitalier | Not yet recruiting |
| Belfort, France, 90000 | |
| Contact: Alain Grentzinger, MD agrentzinger@chbm.fr | |
| Principal Investigator: Alain Grentzinger, MD | |
| University Hospital Jean Minjoz | Recruiting |
| Besancon, France, 25000 | |
| Contact: Nicolas F. Meneveau, MD 33381668624 nicolas.meneveau@univ-fcomte.fr | |
| Contact: Fiona Ecarnot, MSc 33381668539 fiona.ecarnot@univ-fcomte.fr | |
| Sub-Investigator: Francois Schiele, MD | |
| Sub-Investigator: Romain Chopard, MD | |
| Sub-Investigator: Marie-France Seronde, MD | |
| Sub-Investigator: Sebastien Janin, MD | |
| Sub-Investigator: Philoktimon Plastaras, MD | |
| Hôpital Gabriel Montpied | Not yet recruiting |
| Clermont Ferrand, France | |
| Contact: Pascal Motreff, MD 33473751410 pmotreff@chu-clermontferrand.fr | |
| Principal Investigator: Pascal Motreff, MD | |
| Centre Chirurgical Marie Lannelongue | Not yet recruiting |
| Le Plessis Robinson, France | |
| Contact: Christophe Caussin, MD caussin@ccml.fr | |
| Principal Investigator: Christophe Caussin, MD | |
| Centre Hospitalier Universitaire Régional | Not yet recruiting |
| Lille, France | |
| Contact: Eric Van Belle, MD ericvanbelle@aol.com | |
| Principal Investigator: Eric Van Belle, MD | |
| Nouvel Hôpital Civil | Not yet recruiting |
| Strasbourg, France, 67000 | |
| Contact: Patrick Ohlmann, MD 33369550589 patrick.ohlmann@chru-strasbourg.fr | |
| Sub-Investigator: Olivier Morel, MD | |
| Principal Investigator: Patrick Ohlmann, MD | |
| Principal Investigator: | Nicolas F. Meneveau, MD | University Hospital Besancon, France |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Besancon |
| ClinicalTrials.gov Identifier: | NCT01743274 History of Changes |
| Other Study ID Numbers: | P/2012/141 |
| Study First Received: | November 23, 2012 |
| Last Updated: | January 3, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Besancon:
|
acute coronary syndromes non-ST elevation myocardial infarction angioplasty fractional flow reserve optical coherence tomography |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013