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

NCT ID: NCT00371475

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

TAXUS Liberté-SR

Intervention Type: DEVICE

Paclitaxel-Eluting Coronary 38 mm Stent

Arm 2

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

Group Type: OTHER

TAXUS™ Express

Intervention Type: DEVICE

Paclitaxel-Eluting Coronary Stent System

Interventions

TAXUS Liberté-SR

Paclitaxel-Eluting Coronary 38 mm Stent

Intervention Type: DEVICE

TAXUS™ Express

Paclitaxel-Eluting Coronary Stent System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is at least 18 years old.

2. Eligible for percutaneous coronary intervention (PCI)

3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia

4. Left ventricular ejection fraction (LVEF) of at least 25%

5. Acceptable candidate for coronary artery bypass grafting (CABG)

6. 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

7. Willing to comply with all specified follow-up evaluations

1. 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.

2. Successful predilation is mandatory for entry into study

3. Target lesion located within a single native coronary artery

4. 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.

5. Cumulative target lesion length is greater than or equal to 26 mm and less than or equal to 34 mm (visual estimate)

6. Target lesion RVD is greater than or equal to 2.7 mm and less than or equal to 4.0 mm (visual estimate)

7. Target lesion diameter stenosis at least 50% (visual estimate)

8. Target lesion is de novo (i.e., a coronary lesion not previously treated)

Exclusion Criteria

1. Known hypersensitivity to paclitaxel

2. Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.

3. Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel

4. Previous or planned treatment with intravascular brachytherapy in the target vessel

5. Planned CABG within 9-months post-index procedure

6. 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

7. Cerebrovascular Accident (CVA) within the past 6 months

8. Cardiogenic Shock

9. Acute or chronic renal dysfunction

10. Contraindication to ASA, or to both clopidogrel and ticlopidine

11. Leukopenia

12. Thrombocytopenia or thrombocytosis

13. Active peptic ulcer or active gastrointestinal (GI) bleeding

14. Known allergy to stainless steel

15. Any prior true anaphylactic reaction to contrast agents

16. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure

17. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure

18. Male or female with known intention to procreate within 3 months after the index procedure

19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating

20. Life expectancy of less than 24 months due to other medical condition

21. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study

22. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

1. Unprotected and protected left main coronary artery disease (patient with protected left main disease can be enrolled ONLY if the target lesion is in the RCA)

2. Target lesion is ostial in location (within 3.0 mm of vessel origin)

3. Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate

4. Target lesion and/or target vessel proximal to the target lesion is tortuous

5. Target lesion is located within or distal to a >60 degree bend in the vessel

6. Target lesion involves a bifurcation with a side branch vessel >2.0mm in diameter

7. Target lesion is totally occluded (TIMI flow <1), either at baseline or predilation

8. Angiographic presence of probable or definite thrombus

9. Pre-treatment of the target vessel at the index procedure is not allowed with any device except for predilation with balloon angioplasty or cutting balloon.

10. A previously treated lesion within the target vessel:

• <15mm from the target lesion (visual estimate)
• Performed </= 6 months from index procedure
• >30% residual stenosis after previous treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A Ormiston, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital

Mark A Turco, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Adventist Hospital

Peter Maurer, MPH

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Mercy General Hospital

Sacramento, California, United States

Christiana Hospital

Newark, Delaware, United States

Florida Hospital

Orlando, Florida, United States

St. John's Hospital

Springfield, Illinois, United States

The Heart Center

Indianapolis, Indiana, United States

Maine Medical Center

Portland, Maine, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Columbia University Medical Center

New York, New York, United States

Wake Medical Center

Raleigh, North Carolina, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

North Ohio Research Elyria Memorial Hospital

Elyria, Ohio, United States

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

The Pennsylvania State University Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Methodist DeBakey Heart Center

Houston, Texas, United States

Scott & White Memorial Hospital

Temple, Texas, United States

Mercy Angiography Unit, 98 Mountain Road, First Floor

Auckland, Epsom, New Zealand

Auckland City Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

National Heart Centre

Singapore, , Singapore

National University Hospital

Singapore, , Singapore

Countries

United States; New Zealand; Singapore

References

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.

Reference Type: DERIVED

PMID: 23232250 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20129555 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19463432 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19463387 (View on PubMed)

Other Identifiers

TAXUS ATLAS Long Lesion

Identifier Type: -

Identifier Source: secondary_id

S2039

Identifier Type: -

Identifier Source: org_study_id