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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
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
Secondary ID [1] 0 0
03-364
Universal Trial Number (UTN)
Trial acronym
SPIRIT II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
In-stent late loss (LL)
Timepoint [1] 0 0
at 180 days
Secondary outcome [1] 0 0
In-segment Late Loss
Timepoint [1] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [2] 0 0
In-stent Late Loss at 2 years (for a subset of 152 patients)
Timepoint [2] 0 0
at 2 years (for a subset of 152 patients)
Secondary outcome [3] 0 0
Proximal and distal Late Loss
Timepoint [3] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [4] 0 0
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Timepoint [4] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [5] 0 0
In-stent and in-segment percent Diameter Stenosis (% DS)
Timepoint [5] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [6] 0 0
In-stent percent Volume Obstruction (% VO)
Timepoint [6] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [7] 0 0
Plaque behind the stent( by IVUS)
Timepoint [7] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [8] 0 0
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Timepoint [8] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [9] 0 0
Ischemia Driven Target Vessel Failure (ID-TVF)
Timepoint [9] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [10] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [10] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [11] 0 0
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Timepoint [11] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [12] 0 0
Aneurysm, thrombosis and persisting dissection
Timepoint [12] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [13] 0 0
Acute success(device, procedure and clinical)
Timepoint [13] 0 0
Acute

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Denmark
State/province [4] 0 0
Aalborg
Country [5] 0 0
Denmark
State/province [5] 0 0
Aarhus
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Rouen
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
France
State/province [10] 0 0
Tours
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Oeynhausen
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Segeberg
Country [13] 0 0
Germany
State/province [13] 0 0
Dachau
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Kassel
Country [16] 0 0
India
State/province [16] 0 0
New Delhi
Country [17] 0 0
Italy
State/province [17] 0 0
Reggio Emilia
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Breda
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nieuwegein
Country [21] 0 0
Netherlands
State/province [21] 0 0
Rotterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Zwolle
Country [23] 0 0
New Zealand
State/province [23] 0 0
Epsom
Country [24] 0 0
New Zealand
State/province [24] 0 0
Grafton
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
South Africa
State/province [26] 0 0
Cape Town
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Switzerland
State/province [28] 0 0
Basel
Country [29] 0 0
Switzerland
State/province [29] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00180310
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.
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Serruys
Address 0 0
Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00180310