A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions

NCT00371475 | Completed Phase 3 DMC

• 2 other identifiers: S2039TAXUS ATLAS Long Lesion
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 25

Brief Summary

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté 38 mm stent to an historical TAXUS Express control. The control group is a case-matched, blended, long lesion subset population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate clinical outcomes of TAXUS Liberté-SR 38 mm stent in de novo lesions and to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Percent diameter stenosis of the analysis segment at 9-months

  9 Months

Secondary Outcomes (8)

• Clinical procedural and technical success

  5 Years

• Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)

  9 Months

• MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.

  5 Years

• Stent thrombosis rate

  5 Years

• Target Vessel Failure (TVF)

  5 Years

Study Arms (2)

Arm 1

EXPERIMENTAL

Device: TAXUS Liberté-SR

Arm 2

OTHER

Historical Comparator: control data derived from the TAXUS IV and TAXUS V clinical trials

Device: TAXUS™ Express

Interventions

TAXUS Liberté-SR DEVICE

Paclitaxel-Eluting Coronary 38 mm Stent

Arm 1

TAXUS™ Express DEVICE

Paclitaxel-Eluting Coronary Stent System

Arm 2

Eligibility Criteria

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

You may qualify if:

• Patient is at least 18 years old.
• Eligible for percutaneous coronary intervention (PCI)
• Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia
• Left ventricular ejection fraction (LVEF) of at least 25%
• Acceptable candidate for coronary artery bypass grafting (CABG)
• Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
• Willing to comply with all specified follow-up evaluations
• Only one lesion (target lesion) may be treated with the study stent.However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
• Successful predilation is mandatory for entry into study
• Target lesion located within a single native coronary artery
• Target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments) but must be completely covered by one study stent.
• Cumulative target lesion length is greater than or equal to 26 mm and less than or equal to 34 mm (visual estimate)
• Target lesion RVD is greater than or equal to 2.7 mm and less than or equal to 4.0 mm (visual estimate)
• Target lesion diameter stenosis at least 50% (visual estimate)
• Target lesion is de novo (i.e., a coronary lesion not previously treated)

You may not qualify if:

• Known hypersensitivity to paclitaxel
• Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
• Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
• Previous or planned treatment with intravascular brachytherapy in the target vessel
• Planned CABG within 9-months post-index procedure
• MI within 72 hours prior to the index procedure and/or creatine kinase(CK) \>2x the local laboratory's ULN unless CK-MB is \<2x ULN
• Cerebrovascular Accident (CVA) within the past 6 months
• Cardiogenic Shock
• Acute or chronic renal dysfunction
• Contraindication to ASA, or to both clopidogrel and ticlopidine
• Leukopenia
• Thrombocytopenia or thrombocytosis
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Known allergy to stainless steel
• Any prior true anaphylactic reaction to contrast agents

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (25)

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Christiana Hospital

Newark, Delaware, 19718-0002, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

The Heart Center

Indianapolis, Indiana, 46290, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

North Ohio Research Elyria Memorial Hospital

Elyria, Ohio, 44035, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

The Pennsylvania State University Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Methodist DeBakey Heart Center

Houston, Texas, 77030-2767, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Mercy Angiography Unit, 98 Mountain Road, First Floor

Auckland, Epsom, 1003, New Zealand

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, 8001, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

National Heart Centre

Singapore, 168752, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (4)

• Ormiston JA, Charles O, Mann T, Hall JJ, McGarry T, Cannon LA, Webster MW, Mishkel GJ, Underwood PL, Dawkins KD. Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberte paclitaxel-eluting stent in de-novo coronary artery lesions. Coron Artery Dis. 2013 Jan;24(1):61-8. doi: 10.1097/MCA.0b013e32835b3932.

  PMID: 23232250 DERIVED

• Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.

  PMID: 20129555 DERIVED

• Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009.

  PMID: 19463432 DERIVED

• Turco MA, Ormiston JA, Popma JJ, Hall JJ, Mann T, Cannon LA, Webster MW, Mishkel GJ, O'Shaughnessy CD, McGarry TF, Mandinov L, Dawkins KD, Baim DS. Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberte stent: 1-year results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2008 Dec;1(6):699-709. doi: 10.1016/j.jcin.2008.09.007.

  PMID: 19463387 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John A Ormiston, MD

  Mercy Hospital

  PRINCIPAL INVESTIGATOR

• Mark A Turco, MD

  Washington Adventist Hospital

  PRINCIPAL INVESTIGATOR

• Peter Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2006
• First Posted: September 4, 2006
• Study Start: March 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

NZ (4); US (19); SG (2)