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SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System (SPIRIT II)

Primary Purpose

Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
XIENCE V® Everolimus Eluting Coronary Stent
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Wilheminenspital der Stadt Wien
  • A.Z. Middelheim
  • C.H.R. La Citadelle
  • C.H.U. de Liège Sart Tilman
  • Aalborg Sygehus Syd
  • Århus University Hospital
  • Rigshospitalet
  • Hôpital Cochin
  • Clinique Saint Hilaire
  • Clinique Pasteur
  • Hôpital de Rangueil CHU
  • Clinique Saint Gatien
  • Herzzentrum Bad Oeynhausen
  • Segeberger Kliniken GmbH
  • Amper Kliniken AG Klinikum Dachau
  • Herz- und Gefäßzentrum Hamburg
  • Klinikum Kassel
  • Max Devki Devi Heart & Vascular Institute
  • Azienda Ospedaliera Santa Maria Nuova
  • Academisch Medisch Centrum
  • Amphia Hospital
  • St. Antonius Ziekenhuis Nieuwegein
  • Erasmus Medical Center
  • Isala Klinieken - Locatie Weezenlanden
  • The Mercy Hospital
  • Auckland City Hospital
  • National Institute of Cardiology in Warsaw
  • Vergelegen Mediclinic
  • Hospital Clinico San Carlos
  • University Hospital Gregorio Maranon
  • Kantonsspital Basel
  • R.V. Hôpital Cantonal Universitaire de Geneve

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

XIENCE V® Everolimus Eluting Coronary Stent System

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Outcomes

Primary Outcome Measures

In-stent late loss (LL)

Secondary Outcome Measures

In-segment Late Loss
In-stent Late Loss at 2 years (for a subset of 152 patients)
Proximal and distal Late Loss
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
In-stent and in-segment percent Diameter Stenosis (% DS)
In-stent percent Volume Obstruction (% VO)
Plaque behind the stent( by IVUS)
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Ischemia Driven Target Vessel Failure (ID-TVF)
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Aneurysm, thrombosis and persisting dissection
Acute success(device, procedure and clinical)

Full Information

First Posted
September 11, 2005
Last Updated
July 18, 2011
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00180310
Brief Title
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Acronym
SPIRIT II
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
XIENCE V® Everolimus Eluting Coronary Stent System
Arm Title
2
Arm Type
Active Comparator
Arm Description
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
XIENCE V® Everolimus Eluting Coronary Stent
Other Intervention Name(s)
XIENCE V® Everolimus Eluting Coronary Stent System
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Intervention Type
Device
Intervention Name(s)
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Other Intervention Name(s)
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease
Primary Outcome Measure Information:
Title
In-stent late loss (LL)
Time Frame
at 180 days
Secondary Outcome Measure Information:
Title
In-segment Late Loss
Time Frame
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Title
In-stent Late Loss at 2 years (for a subset of 152 patients)
Time Frame
at 2 years (for a subset of 152 patients)
Title
Proximal and distal Late Loss
Time Frame
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Title
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Time Frame
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Title
In-stent and in-segment percent Diameter Stenosis (% DS)
Time Frame
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Title
In-stent percent Volume Obstruction (% VO)
Time Frame
at 180 days and at 2 years for a subset of 152 patients
Title
Plaque behind the stent( by IVUS)
Time Frame
at 180 days and at 2 years for a subset of 152 patients
Title
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Time Frame
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Title
Ischemia Driven Target Vessel Failure (ID-TVF)
Time Frame
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Title
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Title
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Time Frame
at 180 days and at 2 years for a subset of 152 patients
Title
Aneurysm, thrombosis and persisting dissection
Time Frame
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Title
Acute success(device, procedure and clinical)
Time Frame
Acute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Serruys
Organizational Affiliation
Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilheminenspital der Stadt Wien
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
A.Z. Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
C.H.R. La Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
C.H.U. de Liège Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Aalborg Sygehus Syd
City
Aalborg
Country
Denmark
Facility Name
Århus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Clinique Saint Hilaire
City
Rouen
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Hôpital de Rangueil CHU
City
Toulouse
Country
France
Facility Name
Clinique Saint Gatien
City
Tours
Country
France
Facility Name
Herzzentrum Bad Oeynhausen
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Amper Kliniken AG Klinikum Dachau
City
Dachau
Country
Germany
Facility Name
Herz- und Gefäßzentrum Hamburg
City
Hamburg
Country
Germany
Facility Name
Klinikum Kassel
City
Kassel
Country
Germany
Facility Name
Max Devki Devi Heart & Vascular Institute
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Azienda Ospedaliera Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Isala Klinieken - Locatie Weezenlanden
City
Zwolle
Country
Netherlands
Facility Name
The Mercy Hospital
City
Auckland
State/Province
Epsom
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
State/Province
Grafton
Country
New Zealand
Facility Name
National Institute of Cardiology in Warsaw
City
Warsaw
Country
Poland
Facility Name
Vergelegen Mediclinic
City
Cape Town
Country
South Africa
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
University Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Kantonsspital Basel
City
Basel
Country
Switzerland
Facility Name
R.V. Hôpital Cantonal Universitaire de Geneve
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20129545
Citation
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.
Results Reference
background
PubMed Identifier
19755303
Citation
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.
Results Reference
result
PubMed Identifier
19737711
Citation
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.
Results Reference
result
PubMed Identifier
19608482
Citation
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.
Results Reference
result
PubMed Identifier
18926156
Citation
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.
Results Reference
result
Citation
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
Results Reference
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Citation
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
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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
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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
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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
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PubMed Identifier
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Results Reference
derived

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SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

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