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

NCT00180310 | Completed Phase 3 DMC

• 1 other identifier: 03-364
• Study Type: interventional
• Target: 300
• Locations: 13 countries
• Sites: 32

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• In-stent late loss (LL)

  at 180 days

Secondary Outcomes (13)

• In-segment Late Loss

  at 180 days (all patients) and at 2 years (for a subset of 152 patients)

• In-stent Late Loss at 2 years (for a subset of 152 patients)

  at 2 years (for a subset of 152 patients)

• Proximal and distal Late Loss

  at 180 days (all patients) and at 2 years (for a subset of 152 patients)

• In-stent and in-segment Angiographic Binary Restenosis (ABR) rate

  at 180 days (all patients) and at 2 years (for a subset of 152 patients)

• In-stent and in-segment percent Diameter Stenosis (% DS)

  at 180 days (all patients) and at 2 years (for a subset of 152 patients)

Study Arms (2)

1

EXPERIMENTAL

XIENCE V® Everolimus Eluting Coronary Stent System

Device: XIENCE V® Everolimus Eluting Coronary Stent

2

ACTIVE COMPARATOR

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Interventions

XIENCE V® Everolimus Eluting Coronary Stent DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Also known as: XIENCE V® Everolimus Eluting Coronary Stent System

1

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease

Also known as: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

Wilheminenspital der Stadt Wien

Vienna, 1160, Austria

Location

A.Z. Middelheim

Antwerp, 2020, Belgium

Location

C.H.R. La Citadelle

Liège, 4000, Belgium

Location

C.H.U. de Liège Sart Tilman

Liège, 4000, Belgium

Location

Aalborg Sygehus Syd

Aalborg, Denmark

Location

Århus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Cochin

Paris, France

Location

Clinique Saint Hilaire

Rouen, France

Location

Clinique Pasteur

Toulouse, France

Location

Hôpital de Rangueil CHU

Toulouse, France

Location

Clinique Saint Gatien

Tours, France

Location

Herzzentrum Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Amper Kliniken AG Klinikum Dachau

Dachau, Germany

Location

Herz- und Gefäßzentrum Hamburg

Hamburg, Germany

Location

Klinikum Kassel

Kassel, Germany

Location

Max Devki Devi Heart & Vascular Institute

New Delhi, 110017, India

Location

Azienda Ospedaliera Santa Maria Nuova

Reggio Emilia, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Isala Klinieken - Locatie Weezenlanden

Zwolle, Netherlands

Location

The Mercy Hospital

Auckland, Epsom, New Zealand

Location

Auckland City Hospital

Auckland, Grafton, New Zealand

Location

National Institute of Cardiology in Warsaw

Warsaw, Poland

Location

Vergelegen Mediclinic

Cape Town, South Africa

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

University Hospital Gregorio Maranon

Madrid, Spain

Location

Kantonsspital Basel

Basel, Switzerland

Location

R.V. Hôpital Cantonal Universitaire de Geneve

Geneva, Switzerland

Location

Related Publications (18)

• 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.

  PMID: 20129545 BACKGROUND

• 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.

  PMID: 19755303 RESULT

• 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.

  PMID: 19737711 RESULT

• 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.

  PMID: 19608482 RESULT

• 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.

  PMID: 18926156 RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  PMID: 20031737 RESULT

• 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.

  RESULT

• 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.

  PMID: 25940520 DERIVED

• 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.

  PMID: 24746650 DERIVED

• 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.

  PMID: 23339811 DERIVED

• 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.

  PMID: 22115661 DERIVED

• 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.

  PMID: 22017936 DERIVED

• 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.

  PMID: 21232715 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Patrick Serruys

  Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: February 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

NL (5); PL (1); FR (5); DK (3); BE (3); IT (1); AU (1); IN (1); NZ (2); ES (2); CH (2); ZA (1); DE (5)