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

Coronary Stenosis Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403338
• Other study ID #: P03-6323
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2006
• Last updated: October 5, 2009
• Start date: December 2004
• Est. completion date: April 2006

Study information

• Verified date: October 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• CYPHER® Bx Velocity™ stent (sirolimus-eluting)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

References & 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 — View 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 Stat — View Citation