Diabetes Clinical Trial
— OPERAOfficial title:
OPtimized Stenting Using IVUS in Long lEsion: Rationale for Simplified criteriA
Verified date | July 2018 |
Source | Centre Chirurgical Marie Lannelongue |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI
3. 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
Status | Completed |
Enrollment | 300 |
Est. completion date | July 2018 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Chirurgical Marie Lannelongue | Le Plessis Robinson | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Centre Chirurgical Marie Lannelongue | Centre Hospitalier de La Rochelle, Centre Hospitalier de PAU, Centre Hospitalier Universitaire de Nice, Hôpital Cochin, Hôpital de la Timone, Rangueil Hospital, University Hospital, Limoges, Versailles Hospital |
France,
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 sirol — View Citation
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle 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 — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
12 months period after inclusion in the trial | |
Secondary | The incidence of the MACE composite criteria at 6 months, 12 months and 3 years. | 6 months, 12 months and 3 years | ||
Secondary | 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 | 6 months, 12 months and 3 years | |
Secondary | 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. | 6 months, 12 months and 3 years | |
Secondary | Stent thrombosis at 12 months | 12 months | ||
Secondary | 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 |
At 12 months including |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |