SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) - Full Text View

Sponsor:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00180479

Purpose

This study is divided into 5 arms:

Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan

The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.

Condition	Intervention	Phase
Stents Coronary Artery Disease Total Coronary Occlusion Coronary Artery Restenosis Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis	Device: XIENCE V® Everolimus Eluting Coronary Stent Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Vascular Diseases

Drug Information available for: Paclitaxel Everolimus

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Primary Endpoint: In-segment Late Loss (LL) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
Target Vessel Failure (TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Target Vessel Failure (TVF) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Target Vessel Failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Target Vessel Failure (TVF) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 270 days ] [ Designated as safety issue: No ]
Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 1 years ] [ Designated as safety issue: No ]
Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Ischemia Drive Target Vessel Revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Ischemia Driven Major Adverse Cardiac Event(MACE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
In-stent % Angiographic Binary Restenosis (% ABR) Rate [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
In-segment % Angiographic Binary Restenosis (% ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
Acute Success: Clinical Device [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
Acute Success: Clinical Procedure [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
Proximal Late Loss [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
Distal Late Loss [ Time Frame: 240 days ] [ Designated as safety issue: No ]
In-stent Late Loss [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
% Volume Obstruction (% VO) [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
In-stent % Diameter Stenosis (% DS) [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
In-segment % Diameter Stenosis (% DS) [ Time Frame: 240 days ] [ Designated as safety issue: No ]

Enrollment:	1002
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2011
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental XIENCE V® Everolimus Eluting Coronary Stent System	Device: XIENCE V® Everolimus Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease.
2: Active Comparator TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System	Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)

Exclusion Criteria:

Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
Located in a major epicardial vessel that has been previously treated with brachytherapy
Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
Total occlusion (TIMI flow 0), prior to wire passing
The target vessel contains thrombus
Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180479

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Locations

United States, Alabama
Baptist Health System - Montclair
Birmingham, Alabama, United States, 35213
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
United States, Arizona
Arizona Heart Hospital
Phoenix, Arizona, United States, 85016
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 87106
Mercy General Hospital
Sacramento, California, United States, 95819
Scripps Memorial Hospital
La Jolla, California, United States, 92037
Alta Bates Summit Medical Center
Oakland, California, United States, 94609
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Holy Cross Medical Center (prev. North Ridge MC)
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
United States, Illinois
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60148
Rush University Medical Center
Chicago, Illinois, United States, 60612
St. John's Hospital
Springfield, Illinois, United States, 62701
United States, Indiana
The Heart Center of IN, LLC
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
St. Joseph Medical Center
Towson, Maryland, United States, 21204
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
St John Hospital & Medical Center
Detroit, Michigan, United States, 48236
Spectrum Health Hospital
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Montana
St. Patrick Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
Presbyterian Hospital
Albuquerque, New Mexico, United States, 28204
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 87106
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Wake Medical Center
Raleigh, North Carolina, United States, 27610
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
United States, Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Integris Baptist Medical, Inc.
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Sacred Heart Medical Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Pinnacle Health @ Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17043
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Texas
Heart Hospital of Austin
Austin, Texas, United States, 78756
TexSan Heart Hospital
San Antonio, Texas, United States, 78215
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Methodist Hospital
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:

Gregg W Stone, MD

Columbia University

More Information

Publications:

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13.

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. Epub 2009 Jan 26.

Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system:: clinical and angiographic results from the spirit III randomized trial. Catheter Cardiovasc Interv. 2009 Mar 24; [Epub ahead of print]

Responsible Party:	Abbott Vascular ( Abbott Vascular )
Study ID Numbers:	03-360
Study First Received:	September 13, 2005
Results First Received:	October 15, 2008
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00180479 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Vascular:

Everolimus

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Arteriosclerosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Arterial Occlusive Diseases
Everolimus
Heart Diseases
Mitosis Modulators
Vascular Diseases

Ischemia
Antimitotic Agents
Immunosuppressive Agents
Coronary Restenosis
Coronary Stenosis
Thrombosis
Pharmacologic Actions
Coronary Occlusion
Coronary Disease
Embolism and Thrombosis
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 25, 2009