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

Show 65 Study Locations

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 05, 2009