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Coronary DiseasePhase 3SPIRIT IINCT00180310

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

A Phase 3 study testing XIENCE V® Everolimus Eluting Coronary Stent and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 32 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XIENCE V® Everolimus Eluting Coronary Stent and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
32 sitesin 13 countries
Study dates
Jul 2005to Feb 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

32 sites in 13 countries.

32 sites in 13 countries

France5 sites

  • Hôpital Cochin

    Paris

  • Clinique Saint Hilaire

    Rouen

  • Clinique Pasteur

    Toulouse

  • Hôpital de Rangueil CHU

    Toulouse

  • Clinique Saint Gatien

    Tours

Other trials in France

Germany5 sites

  • Herzzentrum Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Amper Kliniken AG Klinikum Dachau

    Dachau

  • Herz- und Gefäßzentrum Hamburg

    Hamburg

  • Klinikum Kassel

    Kassel

Other trials in Germany

Netherlands5 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Amphia Hospital

    Breda

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein

  • Erasmus Medical Center

    Rotterdam

  • Isala Klinieken - Locatie Weezenlanden

    Zwolle

Other trials in Netherlands

Belgium3 sites

  • A.Z. Middelheim

    Antwerp, 2020

  • C.H.R. La Citadelle

    Liège, 4000

  • C.H.U. de Liège Sart Tilman

    Liège, 4000

Other trials in Belgium

Denmark3 sites

  • Aalborg Sygehus Syd

    Aalborg

  • Århus University Hospital

    Aarhus

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

New Zealand2 sites

  • The Mercy Hospital

    Auckland, Epsom

  • Auckland City Hospital

    Auckland, Grafton

Other trials in New Zealand

Spain2 sites

  • Hospital Clinico San Carlos

    Madrid

  • University Hospital Gregorio Maranon

    Madrid

Other trials in Spain

Switzerland2 sites

  • Kantonsspital Basel

    Basel

  • R.V. Hôpital Cantonal Universitaire de Geneve

    Geneva

Other trials in Switzerland

Austria1 site

  • Wilheminenspital der Stadt Wien

    Vienna, 1160

Other trials in Austria

India1 site

  • Max Devki Devi Heart & Vascular Institute

    New Delhi, 110017

Other trials in India

Italy1 site

  • Azienda Ospedaliera Santa Maria Nuova

    Reggio Emilia

Other trials in Italy

Poland1 site

  • National Institute of Cardiology in Warsaw

    Warsaw

Other trials in Poland

South Africa1 site

  • Vergelegen Mediclinic

    Cape Town

Other trials in South Africa

About this study

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

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.

Read the 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.

Being tested
XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Keywords
drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
Medical subject headings
Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XIENCE V® Everolimus Eluting Coronary StentDevice

    Also called XIENCE V® Everolimus Eluting Coronary Stent System

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

  • TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary StentDevice

    Also called TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

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

Study groups in NCT00180310
Study groupRoleWhat they receive
1ExperimentalXIENCE V® Everolimus Eluting Coronary Stent System
Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent
2Active comparatorTAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Receives: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent late loss (LL)

    Measured: at 180 days

Secondary outcomes (13)

  1. In-segment Late Loss

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

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

    Measured: at 2 years (for a subset of 152 patients)

  3. Proximal and distal Late Loss

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

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

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

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

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

  6. In-stent percent Volume Obstruction (% VO)

    Measured: at 180 days and at 2 years for a subset of 152 patients

  7. Plaque behind the stent( by IVUS)

    Measured: at 180 days and at 2 years for a subset of 152 patients

  8. Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate

    Measured: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years

  9. Ischemia Driven Target Vessel Failure (ID-TVF)

    Measured: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years

  10. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Measured: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years

  11. Persisting incomplete stent apposition, late-acquired incomplete stent apposition

    Measured: at 180 days and at 2 years for a subset of 152 patients

  12. Aneurysm, thrombosis and persisting dissection

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

  13. Acute success(device, procedure and clinical)

    Measured: Acute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2007
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00180310
Sponsor's protocol ID
03-364
Acronym
SPIRIT II
Status last verified
Jul 2011
First submitted
11 Sep 2005
Last updated
20 Jul 2011
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 20129545

  • 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.

    PubMed 19755303

  • 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.

    PubMed 19737711

  • 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.

    PubMed 19608482

  • 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.

    PubMed 18926156

  • 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.

    PubMed 20031737

  • 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.

    PubMed 25940520

  • 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.

    PubMed 24746650

  • 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.

    PubMed 23339811

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XIENCE V® Everolimus Eluting Coronary Stent and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 32 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France, Germany, Netherlands, Belgium, Denmark and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent late loss (LL) (time frame: at 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00180310, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.

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