SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System - Full Text View

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00307047

Purpose

Prospective, randomized, active-controlled, single-blinded, multicenter, US clinical trial evaluating the investigational device XIENCE™ V in subjects with reference vessel diameters (RVD) 2.5 mm to 4.25 mm and lesion lengths <= 28 mm; non-inferiority to FDA-approved commercially available TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System (TAXUS™). (NOTE: RVD 2.5 mm to 3.75 mm until 4.0 mm TAXUS™ is commercially available)

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

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Condition	Intervention	Phase
Coronary Artery Disease	Device: XIENCE™ V Everolimus Eluting Coronary Stent Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent	Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: 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 IV Clinical Trial: Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Ischemia driven major adverse cardiac event (MACE) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Ischemia driven 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, and 180 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Acute Success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3690
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Detailed Description:

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE™ V Everolimus Eluting Coronary Stent System (XIENCE™ V EECSS). The XIENCE™ V EECS (XIENCE™ V group) will be compared to an active control represented by FDA-approved commercially available Boston Scientific TAXUS™ EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS™ EXPRESS2™ PECS) System (TAXUS™ group).

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE™ V EECS: TAXUS™ EXPRESS2™ PECS). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) >=2.5 mm to <= 4.25 mm and lesion lengths <=28 mm. (NOTE: RVD >= 2.5 mm to <= 3.75 mm until 4.0 mm TAXUS™ is commercially available) All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, 3, 4, and 5 years.

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 coronary artery with visually estimated diameter of 2.5 mm to 4.25 mm and lesion length <= 28 mm
The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a TIMI flow of >= 1
Non-study percutaneous intervention for lesions in a non-target vessel allowed if per protocol and within protocol defined time frames

Exclusion Criteria:

Lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft
Lesion involves a bifurcation in which the side branch is >= 2 mm in diameter and the ostium of the side branch is > 50% stenosed by visual estimation
Located in a major epicardial vessel that has been previously treated with PCI < 9 months prior to the index procedure
Lesion involves a side branch requiring pre-dilatation
Total occlusion (TIMI flow 0) prior to wire crossing
Restenotic from previous intervention
The target vessel contains thrombus
Subject has received brachytherapy in any epicardial vessel (including side branches)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307047

Show 66 Study Locations

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:

Gregg W Stone

Columbia University Medical Center

More Information

Responsible Party:	Abbott Vascular ( Barbara Nishimoto )
Study ID Numbers:	05-368
Study First Received:	March 23, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00307047
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Vascular:

Stents
Angioplasty
Total coronary occlusion
coronary restenosis
stent thrombosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Everolimus
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis

Coronary Restenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Paclitaxel
Coronary Artery Disease

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mitosis Modulators

Tubulin Modulators
Cardiovascular Diseases
Antimitotic Agents
Immunosuppressive Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009