Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAXUS Liberté™-SR
TAXUS Liberté™-SR
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
General Inclusion Criteria:
- 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
Angiographic Inclusion Criteria:
- 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)
General Exclusion Criteria:
- 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
- Any prior true anaphylactic reaction to contrast agents
- Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
- Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
- Male or female with known intention to procreate within 3 months after the index procedure
- Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
- Life expectancy of less than 24-months due to other medical condition
- 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
- 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:
- Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA)
- Target lesion is ostial in location (within 3.0 mm of vessel origin)
- Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
- Target lesion and/or target vessel proximal to the target lesion is tortuous
- Target lesion is located within or distal to a >60 degree bend in the vessel
- Target lesion involves a bifurcation with a diseased (>50% stenotic)branch vessel >2.0 mm in diameter
- Target lesion is totally occluded (TIMI flow<1) at baseline
- Angiographic presence of probable or definite thrombus
- Pre-treatment of the target vessel at the index procedure is not allowed with any device
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
- Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.
Sites / Locations
- University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems
- Mercy General Hospital
- University of California San Diego Medical Center
- The Medical Center of Aurora
- Florida Hospital
- St. Anthony's Medical Center
- St. John's Hospital
- The Heart Center
- Maine Medical Center
- Washington Adventist Hospital
- Genesys Regional Medical Center
- Northern Michigan Hospital
- St. Mary's Duluth Clinic Regional Heart Center
- Wake Medical Center
- Oklahoma Foundation for Cardiovascular Research
- The Pennsylvania State University Milton S Hershey Medical Center
- Wellmont Holston Valley Medical Center
- Northwest Cardiovascular Research Institute
- Mercy Angiography Unit, 98 Mountain Road, First Floor
- Auckland City Hospital
- Christchurch Hospital
- Dunedin Hospital
- National University Hospital
- National Heart Centre
- Shin Kong Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Arm 1
Arm 2
Arm Description
Control data derived from ATLAS Workhorse Trial
Outcomes
Primary Outcome Measures
Analysis segment percent diameter stenosis at 9-months
Secondary Outcome Measures
Secondary Endpoints: Clinical procedural and technical success
Utilization parameters (equipment utilization, procedure time, fluoroscopic time and amount of contrast used)
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure
Stent thrombosis rate
Target Vessel Failure (TVF)
Target Vessel Revascularization (TVR)
QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume)
Full Information
NCT ID
NCT00371423
First Posted
August 31, 2006
Last Updated
February 1, 2012
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00371423
Brief Title
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Other
Arm Description
Control data derived from ATLAS Workhorse Trial
Intervention Type
Device
Intervention Name(s)
TAXUS Liberté™-SR
Intervention Description
Paclitaxel-Eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
TAXUS Liberté™-SR
Intervention Description
Paclitaxel-Eluting Coronary Stent System
Primary Outcome Measure Information:
Title
Analysis segment percent diameter stenosis at 9-months
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Secondary Endpoints: Clinical procedural and technical success
Time Frame
5 years
Title
Utilization parameters (equipment utilization, procedure time, fluoroscopic time and amount of contrast used)
Time Frame
9 Months
Title
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure
Time Frame
5 Years
Title
Stent thrombosis rate
Time Frame
5 Years
Title
Target Vessel Failure (TVF)
Time Frame
5 Years
Title
Target Vessel Revascularization (TVR)
Time Frame
5 Years
Title
QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)
Time Frame
9 Months
Title
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume)
Time Frame
9 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria:
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
Angiographic Inclusion Criteria:
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)
General Exclusion Criteria:
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
Any prior true anaphylactic reaction to contrast agents
Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
Male or female with known intention to procreate within 3 months after the index procedure
Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
Life expectancy of less than 24-months due to other medical condition
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
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:
Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA)
Target lesion is ostial in location (within 3.0 mm of vessel origin)
Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
Target lesion and/or target vessel proximal to the target lesion is tortuous
Target lesion is located within or distal to a >60 degree bend in the vessel
Target lesion involves a bifurcation with a diseased (>50% stenotic)branch vessel >2.0 mm in diameter
Target lesion is totally occluded (TIMI flow<1) at baseline
Angiographic presence of probable or definite thrombus
Pre-treatment of the target vessel at the index procedure is not allowed with any device
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
Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Ormiston, MD
Organizational Affiliation
Mercy Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Turco, MD
Organizational Affiliation
Washington Adventist Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Maurer, MPH
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8784
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
St. Anthony's Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
The Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
St. Mary's Duluth Clinic Regional Heart Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Wake Medical Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Oklahoma Foundation for Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
The Pennsylvania State University Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Northwest Cardiovascular Research Institute
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Mercy Angiography Unit, 98 Mountain Road, First Floor
City
Auckland
State/Province
Epsom
ZIP/Postal Code
1003
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Heart Centre
City
Singapore
ZIP/Postal Code
168752
Country
Singapore
Facility Name
Shin Kong Memorial Hospital
City
Shih Lin Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23232250
Citation
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.
Results Reference
derived
PubMed Identifier
20129555
Citation
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.
Results Reference
derived
PubMed Identifier
19463432
Citation
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.
Results Reference
derived
PubMed Identifier
19463293
Citation
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.
Results Reference
derived
Learn more about this trial
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
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