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

Coronary Artery Disease Clinical Trial

Official title:

A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Direct Stenting Treatment of Patients With de Novo Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371423
• Other study ID #: S2032
• Secondary ID: TAXUS ATLAS Dire
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2006
• Last updated: February 1, 2012
• Start date: March 2005
• Est. completion date: September 2010

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: September 2010
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

1. Patient is =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 =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 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.

2. Target lesion located within a single native coronary vessel

3. 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.

4. Cumulative target lesion length is =10 mm and =28 mm (visual estimate) and is typically considered appropriate for direct stenting

5. RVD of =2.5 mm to =4.0 mm (visual estimate)

6. Target lesion diameter stenosis =50% (visual estimate)

7. 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. 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

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

5. Planned CABG =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. 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.

12. Leukopenia

13. Thrombocytopenia

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

15. Known allergy to stainless steel

16. Any prior true anaphylactic reaction to contrast agents

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

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

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

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

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

22. 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

23. 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 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 diseased (>50% stenotic)branch vessel >2.0 mm in diameter

7. Target lesion is totally occluded (TIMI flow<1) at baseline

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

10. A previously treated lesion within the target vessel:

• <15 mm from the target lesion (visual estimate)

• Performed </= 6 months from index procedure

• >30% residual stenosis after previous treatment

11. Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.

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 Stent System
• TAXUS Liberté™-SR
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
Taiwan	Shin Kong Memorial Hospital	Shih Lin Taipei
United States	The Medical Center of Aurora	Aurora	Colorado
United States	St. Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	The Pennsylvania State University Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	The Heart Center	Indianapolis	Indiana
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems	Little Rock	Arkansas
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	St. Anthony's Medical Center	Rockford	Illinois
United States	Mercy General Hospital	Sacramento	California
United States	University of California San Diego Medical Center	San Diego	California
United States	Northwest Cardiovascular Research Institute	Spokane	Washington
United States	St. John's Hospital	Springfield	Illinois
United States	Washington Adventist Hospital	Takoma Park	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  New Zealand,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis segment percent diameter stenosis at 9-months		9 Months	Yes
Secondary	Secondary Endpoints: Clinical procedural and technical success		5 years	Yes
Secondary	Utilization parameters (equipment utilization, 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 and area volumes, neointimal area volume)		9 Months	No