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

Coronary Artery Disease Clinical Trial

Official title:

TAXUS ATLAS LONG LESION: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With Long de Novo Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371475
• Other study ID #: S2039
• Secondary ID: TAXUS ATLAS Long
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2006
• Last updated: February 1, 2012
• Start date: March 2005
• Est. completion date: May 2011

Study information

• Verified date: February 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2011
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

General 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

Angiographic Inclusion Criteria:

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)

General 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

Angiographic Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• TAXUS Liberté-SR
Paclitaxel-Eluting Coronary 38 mm Stent
• TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
New Zealand	Mercy Angiography Unit, 98 Mountain Road, First Floor	Auckland	Epsom
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
Singapore	National Heart Centre	Singapore
Singapore	National University Hospital	Singapore
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	St. Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota
United States	North Ohio Research Elyria Memorial Hospital	Elyria	Ohio
United States	The Pennsylvania State University Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Methodist DeBakey Heart Center	Houston	Texas
United States	The Heart Center	Indianapolis	Indiana
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Maine Medical Center	Portland	Maine
United States	Wake Medical Center	Raleigh	North Carolina
United States	Mercy General Hospital	Sacramento	California
United States	St. John's Hospital	Springfield	Illinois
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Scott & White Memorial Hospital	Temple	Texas
United States	North Mississippi Medical Center	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  New Zealand,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent diameter stenosis of the analysis segment at 9-months		9 Months	Yes
Secondary	Clinical procedural and technical success		5 Years	Yes
Secondary	Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)		9 Months	No
Secondary	MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.		5 Years	Yes
Secondary	Stent thrombosis rate		5 Years	Yes
Secondary	Target Vessel Failure (TVF)		5 Years	Yes
Secondary	Target Vessel Revascularization (TVR)		5 Years	Yes
Secondary	QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)		9 Months	No
Secondary	IVUS parameters (percent net volume obstruction, incomplete apposition, stent areas and volume, vessel areas and volume, lumen areas and volume, neointimal area volume)		9 Months	No