Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

NCT00371423 | Completed Phase 3 DMC

• 2 other identifiers: S2032TAXUS ATLAS Direct Stent
• Study Type: interventional
• Target: 247
• Locations: 4 countries
• Sites: 25

Brief Summary

TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Analysis segment percent diameter stenosis at 9-months

  9 Months

Secondary Outcomes (8)

• Secondary Endpoints: Clinical procedural and technical success

  5 years

• Utilization parameters (equipment utilization, 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

Control data derived from ATLAS Workhorse Trial

Device: TAXUS Liberté™-SR

Interventions

TAXUS Liberté™-SR DEVICE

Paclitaxel-Eluting Coronary Stent System

Arm 1

Eligibility Criteria

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

You may qualify if:

• Patient is ≥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 ≥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 appropriate for direct stenting (typically covered by one 24 mm stent or shorter), 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.
• Target lesion located within a single native coronary vessel
• 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 ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting
• RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
• Target lesion diameter stenosis ≥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.
• Previous or 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 ≤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
• Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
• Leukopenia
• Thrombocytopenia
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Known allergy to stainless steel

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (25)

University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems

Little Rock, Arkansas, 72205, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103-8784, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

St. Anthony's Medical Center

Rockford, Illinois, 61108, 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

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, 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

Wake Medical Center

Raleigh, North Carolina, 27610, 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

Northwest Cardiovascular Research Institute

Spokane, Washington, 99204, 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 University Hospital

Singapore, 119074, Singapore

Location

National Heart Centre

Singapore, 168752, Singapore

Location

Shin Kong Memorial Hospital

Shih Lin Taipei, Taiwan

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

• Ormiston JA, Mahmud E, Turco MA, Popma JJ, Weissman N, Cannon LA, Mann T, Lucca MJ, Lim ST, Hall JJ, McClean D, Dobies D, Mandinov L, Baim DS. Direct stenting with the TAXUS Liberte drug-eluting stent: results from the Taxus Atlas Direct Stent Study. JACC Cardiovasc Interv. 2008 Apr;1(2):150-60. doi: 10.1016/j.jcin.2008.01.003.

  PMID: 19463293 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: August 31, 2006
• First Posted: September 4, 2006
• Study Start: March 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: September 1, 2010
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

US (18); NZ (4); TW (1); SG (2)