Coronary Heart DiseaseOPERANCT01861860
OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA
A study testing TAXUS™ Element long stent in people with Coronary Heart Disease and Diabetes, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Diabetes, Vascular Lesions
- What is being tested?
- TAXUS™ Element long stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 10Show fewer
- 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.
Who cannot join
- -Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, Île-de-France Region, 92350
About this study
Official title: OPtimized Stenting Using IVUS in Long lEsion: Rationale for Simplified criteriA
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.
Read more
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
- Conditions
- Coronary Heart Disease, Diabetes, Vascular Lesions, Chronic Total Occlusion of Coronary Artery, Restenosis
- Being tested
- TAXUS™ Element long stent
- Keywords
- stenting using IVUS in long lEsion
- Medical subject headings
- Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAXUS™ Element long stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| New OPERA Criteria | Experimental | TAXUS™ Element long stent Receives: Device: TAXUS™ Element long stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months period after inclusion in the trial
Secondary outcomes (5)
The incidence of the MACE composite criteria at 6 months, 12 months and 3 years.
Measured: 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
Measured: 6 months, 12 months and 3 years
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.
Measured: 6 months, 12 months and 3 years
Stent thrombosis at 12 months
Measured: 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
Measured: At 12 months including
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- PHILIPPE DELEUZE, MD, Principal investigator, CENTRE CHIRUGICAL MARIE LANNELONGUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861860
- Sponsor's protocol ID
- P12-37811002 / 2012-A00696-37
- Acronym
- OPERA
- Status last verified
- Jul 2018
- First submitted
- 16 May 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19228612Fujii 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.
PubMed 14993129Sonoda 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.
PubMed 15172398
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimized Stenting Using IVUS in Long lEsion: Rationale for Simplified criteriA
- ClinicalTrials.gov ID
- NCT01861860
- Acronym / sponsor ID
- OPERA / P12-37811002 / 2012-A00696-37
- Conditions
- Coronary Heart Disease, Diabetes, Vascular Lesions, Chronic Total Occlusion of Coronary Artery, Restenosis
- Keywords
- stenting using IVUS in long lEsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- 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
- Study start
- Oct 2012
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New OPERA Criteria | Experimental | Device: TAXUS™ Element long stentTAXUS™ Element long stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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),
Key exclusion criteria (1 listed)
- -Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAXUS™ Element long stentSegments 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. | Device | New OPERA Criteria |
Primary outcome
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.
Time frame: 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.
5 secondary outcomes
The incidence of the MACE composite criteria at 6 months, 12 months and 3 years.
Time frame: 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.
Time frame: 6 months, 12 months and 3 years
The occurrence of follow-on events over a period of 6 months, 12 months and 3 years.
Time frame: 6 months, 12 months and 3 years
Stent thrombosis at 12 months
Time frame: 12 months
Medico-economics data at 12 months including
Time frame: At 12 months including
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Results publication: PubMed 19228612Serruys 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.
- Results publication: PubMed 14993129Fujii 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 publication: PubMed 15172398Sonoda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PHILIPPE DELEUZE, MD principal investigator
CENTRE CHIRUGICAL MARIE LANNELONGUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAXUS™ Element long stent in people with Coronary Heart Disease and Diabetes, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months period after inclusion in the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01861860, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.