Clinical trial NCT00403338: The Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent (S.T.L.L.R.)
Official title: Prospective Evaluation of the Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent, The e-CYPHER(SM)S.T.L.L.R., Registry [Study of Deployment Technique on Clinical Results]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Keywords: myocardial ischemia
coronary disease
heart disease
Coronary Stenosis [MeSH heading: C14.280.647.250.285]
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients needing an intervention and receiving a CYPHER stent.

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.

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.

Eligibility criteria: Inclusion criteria:

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cordis Corporation, a Johnson & Johnson Co.
name: Amy Orlick
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.