OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA

NCT01861860 | Completed

• 1 other identifier: P12-37811002 / 2012-A00696-37
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

1. 1.MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
2. 2.Safety: procedural Stroke, Urgent cardiac surgery, procedural MI
3. 3.Comparison of IVUS criteria: OPERA, MUSIC, AVIO

Conditions

Coronary Heart Disease; Diabetes; Vascular Lesions; Chronic Total Occlusion of Coronary Artery; Restenosis

Keywords

stenting using IVUS in long lEsion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The incidence of the MACE composite criteria at 6 months, 12 months and 3 years.

  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.

  6 months, 12 months and 3 years

• The occurrence of follow-on events over a period of 6 months, 12 months and 3 years.

  6 months, 12 months and 3 years

• Stent thrombosis at 12 months

  12 months

• Medico-economics data at 12 months including

  At 12 months including

Study Arms (1)

New OPERA Criteria

EXPERIMENTAL

TAXUS™ Element long stent

Device: TAXUS™ Element long stent

Interventions

TAXUS™ Element long stent DEVICE

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.

New OPERA Criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• people with a lesion that is accessible to IVUS after stenting
• people who have provided consent for collection of medical data for this trial.

You may not qualify if:

• Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead
• Hôpital Cochin: collaborator
• Centre Hospitalier de La Rochelle: collaborator
• University Hospital, Limoges: collaborator
• Hôpital de la Timone: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Centre Hospitalier de PAU: collaborator
• Rangueil Hospital: collaborator
• Versailles Hospital: collaborator

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

Location

Related Publications (3)

• 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.

  PMID: 19228612 RESULT

• 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.

  PMID: 14993129 RESULT

• 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.

  PMID: 15172398 RESULT

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• PHILIPPE DELEUZE, MD

  CENTRE CHIRUGICAL MARIE LANNELONGUE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 24, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2018
• Last Updated: January 23, 2020

Record last verified: 2018-07

Locations

FR (1)