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

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 XIENCE™ V Everolimus Eluting Coronary Stent System is an Investigational device. Limited by Federal (U.S.) law to investigational use only.

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

Genetics Home Reference related topics:

Coronary Artery Disease Vascular Diseases

MedlinePlus related topics:

Coronary Artery Disease Heart Diseases Vascular Diseases

ChemIDplus related topics:

Paclitaxel Everolimus

U.S. FDA Resources

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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Primary Endpoint: In-segment late loss (LL) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Major Secondary Endpoint: Ischemia driven target vessel failure (TVF) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Target vessel failure (TVF) [ Time Frame: at 30, 180 days, and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Ischemia driven target lesion revascularization (TLR) [ Time Frame: at 30, 180 and 270 days, and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Ischemia driven target vessel revascularization (TVR) [ Time Frame: at 30, 180 and 270 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Ischemia driven major adverse cardiac event (MACE) [ Time Frame: at 30, 180 and 270 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
Proximal and distal LL [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent LL [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent and in-segment % angiographic binary restenosis (% ABR) rate [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent and in-segment % diameter stenosis (% DS) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent % volume obstruction (% VO) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]

Enrollment:	1002
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (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

Show 65 Study Locations

Sponsors and Collaborators

Abbott Vascular

Investigators


Principal Investigator:	Gregg W Stone, MD	Columbia University Medical Center

More Information

Publications indexed to this study:

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.

Responsible Party:	Abbott Vascular ( Abbott Vascular )
Study ID Numbers:	03-360
First Received:	September 13, 2005
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00180479
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Vascular:

Everolimus

Study placed in the following topic categories:

Everolimus

Arterial Occlusive Diseases

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Constriction, Pathologic

Arteriosclerosis

Ischemia

Coronary Restenosis

Coronary Stenosis

Thrombosis

Coronary Disease

Coronary Occlusion

Signs and Symptoms

Embolism and Thrombosis

Pathologic Processes

Paclitaxel

Embolism

Coronary Artery Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Mitosis Modulators

Physiological Effects of Drugs

Antimitotic Agents

Immunosuppressive Agents

Pharmacologic Actions

Pathological Conditions, Signs and Symptoms

Therapeutic Uses

Tubulin Modulators

Cardiovascular Diseases

Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 14, 2008

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