OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA (OPERA)
Primary Purpose
Coronary Heart Disease, Diabetes, Vascular Lesions
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TAXUS™ Element long stent
Sponsored by

About this trial
This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring stenting using IVUS in long lEsion
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Patients who have had a coronary angioplasty with implantation of a TAXUS™ Element™ stent of 28, 32 and 38 mm in length and up to 3 stents per patient in the case of acute occlusive dissection deployed using IVUS
- Patients with indication of Taxus™ Element™ stent included in the List of Reimbursable Products and Supplies (LPPR):
- diabetes,
- small vessel (less than 3 mm in diameter),
- long lesion(s) (more than 15 mm long),
- chronic total occlusion > 1 month,
- intra-stent restenosis with the exclusion drug eluting stent(s), restenosis of
- people with a lesion that is accessible to IVUS after stenting
- people who have provided consent for collection of medical data for this trial.
Exclusion Criteria:
-Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up
Sites / Locations
- Centre Chirurgical Marie Lannelongue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
New OPERA Criteria
Arm Description
TAXUS™ Element long stent
Outcomes
Primary Outcome Measures
The incidence of MACE composite criteria among patients who received a TAXUS long stent deployed using IVUS according to the OPERA criteria according to the LPPR during a 12 months period after inclusion in the trial.
The MACE composite criteria includes all cardiac deaths and infarctions in the regions of treated lesions as well as revascularization of treated lesions (via iterative angioplasty or aortocoronary bypass) of lesion(s) that receive TAXUS long stent according to the Commission Evaluation of Products and Service (CEPP) over a 12 months period after inclusion in the trial.
To demonstrate improvement of MACE during deployment of 28, 32 and 38 mm TAXUS™ Element™ stents using IVUS. The main objective of the trial is the collection of health data, especially the rate of serious cardiac events at 12 months in the indications recognized by the LPPR. These events are represented by a MACE composite criteria at 1 year, including all cardiac deaths and infarctions in the region of the stented artery and revascularization of the stented artery (TVR) where the reference population is the OTELLO population.
Secondary Outcome Measures
The incidence of the MACE composite criteria at 6 months, 12 months and 3 years.
The incidence of individual components of the MACE composite criteria at 6 months, 12 months and 3 years.
Cardiac deaths and infarctions in the region of the stented artery, revascularization of the stented artery
The occurrence of follow-on events over a period of 6 months, 12 months and 3 years.
Death from all causes, all myocardia infarctions, all revascularizations.
Stent thrombosis at 12 months
Medico-economics data at 12 months including
the number of secondary hospitalizations for cardiac problems
the number of hospitalizations for problem non cardiac but associated with the procedure
the number of new coronary angiographies
the number de new angioplasties
the number of Coronary Artery Bypass Grafting (CABG)
the number and type of other additional examinations
the number and type of special consultations during the monitoring period
Full Information
NCT ID
NCT01861860
First Posted
May 16, 2013
Last Updated
January 21, 2020
Sponsor
Centre Chirurgical Marie Lannelongue
Collaborators
Hôpital Cochin, Centre Hospitalier de La Rochelle, University Hospital, Limoges, Hôpital de la Timone, Centre Hospitalier Universitaire de Nice, Centre Hospitalier de PAU, Rangueil Hospital, Versailles Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01861860
Brief Title
OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA
Acronym
OPERA
Official Title
OPtimized Stenting Using IVUS in Long lEsion: Rationale for Simplified criteriA
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
Collaborators
Hôpital Cochin, Centre Hospitalier de La Rochelle, University Hospital, Limoges, Hôpital de la Timone, Centre Hospitalier Universitaire de Nice, Centre Hospitalier de PAU, Rangueil Hospital, Versailles Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization (AVIO) study was performed with (medical device's type )Promus stent, results are promising, but the study was not designed for clinical endpoint.
There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were recently proposed for complex lesions, but these criteria also have some issues and the complexity make their routine use challenging.
We performed a pilot study for long complex lesion analysis using IVUS, in order to define easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The new criteria (OPERA) are an adaptation of the MUSIC criteria.
OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the study.
Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element stent deployment?
Study design This study will consist to prospectively include consecutive patients with>28mm taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients from the OTELLO study, with the same inclusion criteria, will composed the control group . Population will be matched using the propensity score.
20 to 30 French centers involved in OTELLO study will be contacted for participating in OPERA.
Hypothesis:
Long lesion percutaneous coronary intervention(PCI) have specific characteristics like Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA criteria have better outcomes than without IVUS
Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm implantation
Secondary endpoint
MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
Safety: procedural Stroke, Urgent cardiac surgery, procedural MI
Comparison of IVUS criteria: OPERA, MUSIC, AVIO
Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric study propensity score matched analysis matched for comparison to OTELLO study. (Same inclusion criteria as OTELLO)
Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions.
Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts
Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months telephone contact
Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery, According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Diabetes, Vascular Lesions, Chronic Total Occlusion of Coronary Artery, Restenosis
Keywords
stenting using IVUS in long lEsion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New OPERA Criteria
Arm Type
Experimental
Arm Description
TAXUS™ Element long stent
Intervention Type
Device
Intervention Name(s)
TAXUS™ Element long stent
Intervention Description
Segments are selected using bifurcation branch take-off. The reference is selected or estimated on both sides of the bifurcation and is applied to the concerned segment. The objective is to attain > 80% of the reference cross-sectional areas (CSA) per segment. The balloon diameter is adapted to the endoluminal diameter of the reference.
Primary Outcome Measure Information:
Title
The incidence of MACE composite criteria among patients who received a TAXUS long stent deployed using IVUS according to the OPERA criteria according to the LPPR during a 12 months period after inclusion in the trial.
Description
The MACE composite criteria includes all cardiac deaths and infarctions in the regions of treated lesions as well as revascularization of treated lesions (via iterative angioplasty or aortocoronary bypass) of lesion(s) that receive TAXUS long stent according to the Commission Evaluation of Products and Service (CEPP) over a 12 months period after inclusion in the trial.
To demonstrate improvement of MACE during deployment of 28, 32 and 38 mm TAXUS™ Element™ stents using IVUS. The main objective of the trial is the collection of health data, especially the rate of serious cardiac events at 12 months in the indications recognized by the LPPR. These events are represented by a MACE composite criteria at 1 year, including all cardiac deaths and infarctions in the region of the stented artery and revascularization of the stented artery (TVR) where the reference population is the OTELLO population.
Time Frame
12 months period after inclusion in the trial
Secondary Outcome Measure Information:
Title
The incidence of the MACE composite criteria at 6 months, 12 months and 3 years.
Time Frame
6 months, 12 months and 3 years
Title
The incidence of individual components of the MACE composite criteria at 6 months, 12 months and 3 years.
Description
Cardiac deaths and infarctions in the region of the stented artery, revascularization of the stented artery
Time Frame
6 months, 12 months and 3 years
Title
The occurrence of follow-on events over a period of 6 months, 12 months and 3 years.
Description
Death from all causes, all myocardia infarctions, all revascularizations.
Time Frame
6 months, 12 months and 3 years
Title
Stent thrombosis at 12 months
Time Frame
12 months
Title
Medico-economics data at 12 months including
Description
the number of secondary hospitalizations for cardiac problems
the number of hospitalizations for problem non cardiac but associated with the procedure
the number of new coronary angiographies
the number de new angioplasties
the number of Coronary Artery Bypass Grafting (CABG)
the number and type of other additional examinations
the number and type of special consultations during the monitoring period
Time Frame
At 12 months including
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Patients who have had a coronary angioplasty with implantation of a TAXUS™ Element™ stent of 28, 32 and 38 mm in length and up to 3 stents per patient in the case of acute occlusive dissection deployed using IVUS
Patients with indication of Taxus™ Element™ stent included in the List of Reimbursable Products and Supplies (LPPR):
diabetes,
small vessel (less than 3 mm in diameter),
long lesion(s) (more than 15 mm long),
chronic total occlusion > 1 month,
intra-stent restenosis with the exclusion drug eluting stent(s), restenosis of
people with a lesion that is accessible to IVUS after stenting
people who have provided consent for collection of medical data for this trial.
Exclusion Criteria:
-Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PHILIPPE DELEUZE, MD
Organizational Affiliation
CENTRE CHIRUGICAL MARIE LANNELONGUE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
State/Province
Ile De France
ZIP/Postal Code
92350
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19228612
Citation
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
Results Reference
result
PubMed Identifier
14993129
Citation
Fujii K, Mintz GS, Kobayashi Y, Carlier SG, Takebayashi H, Yasuda T, Moussa I, Dangas G, Mehran R, Lansky AJ, Reyes A, Kreps E, Collins M, Colombo A, Stone GW, Teirstein PS, Leon MB, Moses JW. Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis. Circulation. 2004 Mar 9;109(9):1085-8. doi: 10.1161/01.CIR.0000121327.67756.19. Epub 2004 Mar 1.
Results Reference
result
PubMed Identifier
15172398
Citation
Sonoda S, Morino Y, Ako J, Terashima M, Hassan AH, Bonneau HN, Leon MB, Moses JW, Yock PG, Honda Y, Kuntz RE, Fitzgerald PJ; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol. 2004 Jun 2;43(11):1959-63. doi: 10.1016/j.jacc.2004.01.044.
Results Reference
result
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OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA
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