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CompletedNCT00403338Updated Oct 7, 2009

The Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent (S.T.L.L.R.)

An observational study in Coronary Stenosis, sponsored by Cordis Corporation. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-07.

Sponsored by Cordis Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Geographical miss has been associated with treatment failures after intracoronary radiation therapy. This phenomenon, which is secondary to vascular injury outside the treated segment, was strongly correlated with the development of restenosis at the edges of the treated coronary segment. The European and Canadian SIRIUS trials (E and C-SIRIUS) randomized 350 patients with similar baseline characteristics of the US SIRIUS study. Operators used shorter post-dilatation balloons and direct stented 27% of the patients, achieving a 4.0% TLR rate and a 5.1% in-lesion binary restenosis. These somewhat superior results support the concept that refinement in deployment techniques may further improve clinical outcomes of drug-eluting stents.

02

Conditions studied

  • Coronary Stenosis

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Keywords

  • myocardial ischemia
  • coronary disease
  • heart disease
  • Coronary Stenosis [MeSH heading: C14.280.647.250.285]
03

In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's enrollment of 1,500 is above the median of 200 across 132 observational studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients needing an intervention and receiving a CYPHER stent.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (actual)

Interventions

  • DeviceCYPHER® Bx Velocity™ stent (sirolimus-eluting)
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 18549844 ↗
  • 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. PubMed 19455662 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00403338
Lead sponsor
Cordis Corporation
First posted
Nov 23, 2006
Start date
Dec 2004
Completion
Apr 2006
Last update
Oct 7, 2009

Study contacts

Amy Orlick
study director · Cordis Corporation, a Johnson & Johnson Co.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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