NCT01182649

Brief Summary

Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Mar 2007

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
Last Updated

August 17, 2010

Status Verified

May 1, 2010

Enrollment Period

1.8 years

First QC Date

August 9, 2010

Last Update Submit

August 16, 2010

Conditions

Coronary Artery DiseaseCoronary Atherosclerosis

Keywords

Drug Eluting StentsEverolimus Eluting StentCoronary Angioplasty

Outcome Measures

Primary Outcomes (1)

  • Target Vessel Revascularization

    Incidence of clinically driven target vessel revascularization at 2 year follow up

    2 year

Secondary Outcomes (3)

  • cardiac death

    2 year

  • non fatal myocardial infarction

    2 year

  • stent thrombosis

    2 year

Study Arms (2)

EES Group

EXPERIMENTAL

Patients who received an everolimus eluting stent

Device: coronary stent

SES Gruop

ACTIVE COMPARATOR

Patients who received a sirolimus eluting stent

Device: stent

Interventions

coronary stentDEVICE

coronary angioplasty with stent implantation

Also known as: XIENCE V drug eluting stent; Abbot Vascular USA
EES Group
stentDEVICE

coronary angioplasty with stent implantation

Also known as: CYPHER drug eluting stent; Johnson & Johnson USA
SES Gruop

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)

You may not qualify if:

  • Contraindication to dual antiplatelet therapy for 12 months
  • Known allergy to sirolimus or everolimus
  • Major surgical procedure planned within 1 month
  • History, symptoms, or findings suggestive of aortic dissection.
  • Participation in other trials
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology Aorn Moscati

Avellino, 83100, Italy

Location

Related Publications (4)

  • Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.

    PMID: 20445180BACKGROUND

  • Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.

    PMID: 20060578BACKGROUND

  • Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077.

    PMID: 19712798BACKGROUND

  • Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.

    PMID: 19781402BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • EMILIO DI LORENZO, MD PhD

    DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 17, 2010

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2010

Last Updated

August 17, 2010

Record last verified: 2010-05

Locations

IT(1)