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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00180310
Registration number
NCT00180310
Ethics application status
Date submitted
11/09/2005
Date registered
16/09/2005
Date last updated
20/07/2011
Titles & IDs
Public title
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
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Scientific title
A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
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Secondary ID [1]
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03-364
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Universal Trial Number (UTN)
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Trial acronym
SPIRIT II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Disease
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Coronary Artery Disease
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Coronary Restenosis
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - XIENCE V® Everolimus Eluting Coronary Stent
Treatment: Devices - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Experimental: 1 - XIENCE V® Everolimus Eluting Coronary Stent System
Active comparator: 2 - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Treatment: Devices: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Treatment: Devices: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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In-stent late loss (LL)
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Assessment method [1]
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Timepoint [1]
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at 180 days
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Secondary outcome [1]
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In-segment Late Loss
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Assessment method [1]
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Timepoint [1]
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at 180 days (all patients) and at 2 years (for a subset of 152 patients)
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Secondary outcome [2]
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In-stent Late Loss at 2 years (for a subset of 152 patients)
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Assessment method [2]
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Timepoint [2]
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at 2 years (for a subset of 152 patients)
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Secondary outcome [3]
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Proximal and distal Late Loss
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Assessment method [3]
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Timepoint [3]
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at 180 days (all patients) and at 2 years (for a subset of 152 patients)
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Secondary outcome [4]
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In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
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Assessment method [4]
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Timepoint [4]
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at 180 days (all patients) and at 2 years (for a subset of 152 patients)
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Secondary outcome [5]
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In-stent and in-segment percent Diameter Stenosis (% DS)
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Assessment method [5]
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at 180 days (all patients) and at 2 years (for a subset of 152 patients)
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Secondary outcome [6]
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In-stent percent Volume Obstruction (% VO)
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Assessment method [6]
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Timepoint [6]
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at 180 days and at 2 years for a subset of 152 patients
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Secondary outcome [7]
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Plaque behind the stent( by IVUS)
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Assessment method [7]
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Timepoint [7]
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at 180 days and at 2 years for a subset of 152 patients
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Secondary outcome [8]
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Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
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Assessment method [8]
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Timepoint [8]
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at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
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Secondary outcome [9]
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Ischemia Driven Target Vessel Failure (ID-TVF)
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Assessment method [9]
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Timepoint [9]
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at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
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Secondary outcome [10]
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Ischemia Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [10]
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Timepoint [10]
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at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
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Secondary outcome [11]
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Persisting incomplete stent apposition, late-acquired incomplete stent apposition
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Assessment method [11]
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Timepoint [11]
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at 180 days and at 2 years for a subset of 152 patients
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Secondary outcome [12]
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Aneurysm, thrombosis and persisting dissection
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Assessment method [12]
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Timepoint [12]
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at 180 days (all patients) and at 2 years (for a subset of 152 patients)
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Secondary outcome [13]
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Acute success(device, procedure and clinical)
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Assessment method [13]
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Timepoint [13]
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Acute
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Eligibility
Key inclusion criteria
* De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate
* 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 is allowed if done >= 90 days prior to the index procedure or if planned to be done > 9 months after the index procedure
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure
* Target lesion(s) restenotic from previous intervention
* Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy
* Target vessel(s) contains visible thrombus
* Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
* Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2011
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Sample size
Target
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Accrual to date
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Final
300
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Austria
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Vienna
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Belgium
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Antwerpen
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Belgium
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Liège
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Denmark
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Aalborg
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Denmark
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Aarhus
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Denmark
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Copenhagen
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France
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Paris
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France
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Rouen
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France
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Toulouse
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France
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Tours
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Germany
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Bad Oeynhausen
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Germany
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Bad Segeberg
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Germany
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Dachau
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Germany
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Hamburg
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Germany
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Kassel
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India
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New Delhi
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Italy
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Reggio Emilia
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Netherlands
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Zwolle
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New Zealand
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Epsom
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New Zealand
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Grafton
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Poland
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Warsaw
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South Africa
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Cape Town
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Spain
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Madrid
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Switzerland
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Basel
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Switzerland
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Geneva
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System. TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.
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Trial website
https://clinicaltrials.gov/study/NCT00180310
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Trial related presentations / publications
Garg S, Serruys P, Onuma Y, Dorange C, Veldhof S, Miquel-Hebert K, Sudhir K, Boland J, Huber K, Garcia E, te Riele JA; SPIRIT II Investigators. 3-year clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1190-8. doi: 10.1016/j.jcin.2009.10.002. Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94. Ruygrok PN, Desaga M, Van Den Branden F, Rasmussen K, Suryapranata H, Dorange C, Veldhof S, Serruys PW. One year clinical follow-up of the XIENCE V Everolimus-eluting stent system in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II study. EuroIntervention. 2007 Nov;3(3):315-20. doi: 10.4244/eijv3i3a58. Khattab AA, Richardt G, Verin V, Kelbaek H, Macaya C, Berland J, Miquel-Hebert K, Dorange C, Serruys PW. Differentiated analysis of an everolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial. EuroIntervention. 2008 Mar;3(5):566-73. doi: 10.4244/eijv3i5a102. Wiemer M, Seth A, Chandra P, Neuzner J, Richardt G, Piek JJ, Desaga M, Macaya C, Bol CJ, Miquel-Hebert K, De Roeck K, Serruys PW. Systemic exposure of everolimus after stent implantation: a pharmacokinetic study. Am Heart J. 2008 Oct;156(4):751.e1-7. doi: 10.1016/j.ahj.2008.07.005. SPIRIT II study: A clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions. Serruys Patrick W (Reprint). Erasmus MC, Ctr Thorax, Rotterdam, Netherlands. Journal of the American College of Cardiology 51 ( 10, Suppl. A ): p A261 MAR 11 2008 A clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with cle novo native coronary artery lesions. Ruygrok Peter(Reprint). Auckland City Hosp, Auckland, New Zealand Journal: Journal of the American College of Cardiology 49 ( 9, Suppl. B ): p 28B-29B MAR 6 2007 2007 i2 Summit 2007 on Innovation in Intervention New Orleans, LA, USA March 24 -27, 2007; 20070324 ISSN: 0735-1097 A clinical evaluation of the XIENCE V Everolimus Eluting CSS in the treatment of patients with de novo, native coronary artery lesions. Pharmaco kinetic substudy. Seth A (Reprint); Neuzner J; Richardt G; Wiemer M; Piek J J; Desaga M; Macaya C; Serruys P W; Spirit II Investigators (Reprint) Author Address: Max Hosp, Vasc Inst, New Delhi, India. European Heart Journal 27 ( Suppl. 1 ): p 767 AUG 2006 2006 World Congress of Cardiology Barcelona, SPAIN September 02 -06, 2006; 20060902 ISSN: 0195-668X Document Type: Meeting; Meeting Poster Serruys, P. SPIRIT II Study: A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions. European Society of Cardiology - ESC Congress 2006 Serruys, P. SPIRIT II Clinical Study: A clinical evaluation of the XIENCE™ V Everolimus Eluting CSS in the treatment of patients with de novo, native coronary artery lesions - IVUS substudy. Transcatheter Cardiovascular Therapeutics - TCT Congress 2006 Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O, Suttorp MJ, Tijssen JG, Miquel-Hebert K, Veldhof S, Henriques JP, Serruys PW, Piek JJ. Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial. Circ Cardiovasc Interv. 2009 Aug;2(4):339-47. doi: 10.1161/CIRCINTERVENTIONS.108.831800.108.831800. Epub 2009 Jul 22. Onuma Y and Serruys P. The SPIRIT II Study - A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions: 4 Year Clinical Results. American College of Cardiology - ACC '10& i2 Summit 2010. Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362. Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16. Onuma Y, Miquel-Hebert K, Serruys PW; SPIRIT II Investigators. Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial. EuroIntervention. 2013 Jan 22;8(9):1047-51. doi: 10.4244/EIJV8I9A161. Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016. Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018. Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and 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) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8. doi: 10.1016/j.jcin.2010.07.017.
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Public notes
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Contacts
Principal investigator
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Patrick Serruys
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Address
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Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A,...
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Journal
Ruygrok PN, Desaga M, Van Den Branden F, Rasmussen...
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Khattab AA, Richardt G, Verin V, Kelbaek H, Macaya...
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Wiemer M, Seth A, Chandra P, Neuzner J, Richardt G...
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SPIRIT II study: A clinical evaluation of the XIEN...
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A clinical evaluation of the XIENCE V everolimus e...
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A clinical evaluation of the XIENCE V Everolimus E...
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Serruys, P. SPIRIT II Study: A Clinical Evaluation...
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Serruys, P. SPIRIT II Clinical Study: A clinical e...
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Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manar...
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Onuma Y and Serruys P. The SPIRIT II Study - A Cli...
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Results not provided in
https://clinicaltrials.gov/study/NCT00180310
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