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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180310
• Other study ID #: 03-364
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: July 18, 2011
• Start date: July 2005
• Est. completion date: February 2011

Study information

• Verified date: July 2011
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2011
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
• TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease

Locations

Country	Name	City	State
Austria	Wilheminenspital der Stadt Wien	Vienna
Belgium	A.Z. Middelheim	Antwerpen
Belgium	C.H.R. La Citadelle	Liège
Belgium	C.H.U. de Liège Sart Tilman	Liège
Denmark	Aalborg Sygehus Syd	Aalborg
Denmark	Århus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
France	Hôpital Cochin	Paris
France	Clinique Saint Hilaire	Rouen
France	Clinique Pasteur	Toulouse
France	Hôpital de Rangueil CHU	Toulouse
France	Clinique Saint Gatien	Tours
Germany	Herzzentrum Bad Oeynhausen	Bad Oeynhausen
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Amper Kliniken AG Klinikum Dachau	Dachau
Germany	Herz- und Gefäßzentrum Hamburg	Hamburg
Germany	Klinikum Kassel	Kassel
India	Max Devki Devi Heart & Vascular Institute	New Delhi
Italy	Azienda Ospedaliera Santa Maria Nuova	Reggio Emilia
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Isala Klinieken - Locatie Weezenlanden	Zwolle
New Zealand	Auckland City Hospital	Auckland	Grafton
New Zealand	The Mercy Hospital	Auckland	Epsom
Poland	National Institute of Cardiology in Warsaw	Warsaw
South Africa	Vergelegen Mediclinic	Cape Town
Spain	Hospital Clinico San Carlos	Madrid
Spain	University Hospital Gregorio Maranon	Madrid
Switzerland	Kantonsspital Basel	Basel
Switzerland	R.V. Hôpital Cantonal Universitaire de Geneve	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  India,  Italy,  Netherlands,  New Zealand,  Poland,  South Africa,  Spain,  Switzerland, 

References & Publications (11)

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 Co

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

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 paclitax — View Citation

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-elu — View Citation

Garg S, Serruys P, Onuma Y, Dorange C, Veldhof S, Miquel-Hébert 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. — View 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 SPI — View 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: t — View Citation

Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrié 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 SPI — View Citation

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

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

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: — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late loss (LL)		at 180 days	Yes
Secondary	In-segment Late Loss		at 180 days (all patients) and at 2 years (for a subset of 152 patients)	Yes
Secondary	In-stent Late Loss at 2 years (for a subset of 152 patients)		at 2 years (for a subset of 152 patients)	Yes
Secondary	Proximal and distal Late Loss		at 180 days (all patients) and at 2 years (for a subset of 152 patients)	Yes
Secondary	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)	Yes
Secondary	In-stent and in-segment percent Diameter Stenosis (% DS)		at 180 days (all patients) and at 2 years (for a subset of 152 patients)	Yes
Secondary	In-stent percent Volume Obstruction (% VO)		at 180 days and at 2 years for a subset of 152 patients	Yes
Secondary	Plaque behind the stent( by IVUS)		at 180 days and at 2 years for a subset of 152 patients	Yes
Secondary	Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate		at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years	Yes
Secondary	Ischemia Driven Target Vessel Failure (ID-TVF)		at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years	Yes
Secondary	Ischemia Driven Target Lesion Revascularization (ID-TLR)		at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years	Yes
Secondary	Persisting incomplete stent apposition, late-acquired incomplete stent apposition		at 180 days and at 2 years for a subset of 152 patients	Yes
Secondary	Aneurysm, thrombosis and persisting dissection		at 180 days (all patients) and at 2 years (for a subset of 152 patients)	Yes
Secondary	Acute success(device, procedure and clinical)		Acute	Yes