NCT00403338

Brief Summary

1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

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

December 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

October 7, 2009

Status Verified

October 1, 2009

First QC Date

November 22, 2006

Last Update Submit

October 5, 2009

Conditions

Coronary Stenosis

Keywords

myocardial ischemiacoronary diseaseheart diseaseCoronary Stenosis [MeSH heading: C14.280.647.250.285]

Interventions

CYPHER® Bx Velocity™ stent (sirolimus-eluting)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients needing an intervention and receiving a CYPHER stent.

You may qualify if:

  • Diagnosis of de novo stenosis in major coronary artery
  • Can be treated with stents
  • Candidate for bypass

You may not qualify if:

  • Recent, severe MI
  • Prior brachytherapy
  • Impaired left ventricle function
  • Heart transplant recipient
  • Impaired renal function
  • Disease in vein grafts from previous bypass
  • Similar treatment within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Costa MA, Angiolillo DJ, Tannenbaum M, Driesman M, Chu A, Patterson J, Kuehl W, Battaglia J, Dabbons S, Shamoon F, Flieshman B, Niederman A, Bass TA; STLLR Investigators. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol. 2008 Jun 15;101(12):1704-11. doi: 10.1016/j.amjcard.2008.02.053. Epub 2008 Apr 9.

    PMID: 18549844RESULT

  • Suzuki N, Angiolillo DJ, Tannenbaum MA, Driesman MH, Smith C, Bikkina M, Meckel CR, Morales CE, Xenopoulos NP, Coletta JE, Bezerra HG, Bass TA, Costa MA. Strategies for drug-eluting stent treatment of bifurcation coronary artery disease in the United States: insights from the e-Cypher S.T.L.L.R.trial. Catheter Cardiovasc Interv. 2009 Jun 1;73(7):890-7. doi: 10.1002/ccd.21796.

    PMID: 19455662RESULT

MeSH Terms

Conditions

Coronary StenosisMyocardial IschemiaCoronary DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesVascular Diseases

Study Officials

  • Amy Orlick

    Cordis Corporation, a Johnson & Johnson Co.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

December 1, 2004

Study Completion

April 1, 2006

Last Updated

October 7, 2009

Record last verified: 2009-10