CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
CYPHER Sirolimus-eluting Coronary Stentdevice
Likely dose
2.25mm Cypher sirolimus-eluting stentAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years, male or non-pregnant female
  • ✓Angina pectoris (CCS Class I-IV) or unstable angina (Braunwald Class B&C, I-II) or documented silent ischemia
  • ✓Target lesion ≤20 mm in length
  • ✓Target lesion stenosis >50% and <100%
Key exclusion· 4
  • ✕Myocardial infarction with CK >2× normal within 24 hours prior, unless CK and CK-MB normalized by treatment time
  • ✕Unstable angina classified as Braunwald III B or C, or peri-infarction status
  • ✕Left ventricular ejection fraction ≤25%
  • ✕Impaired renal function (creatinine >3.0 mg/dL)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00232739
NCT00232739Phase 3Completed
CompareCT.gov

A Multicenter, Non-Randomized Study of the 2.25mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Cordis US Corp.·interventional·Posted Oct 5, 2005·Updated Mar 16, 2010

In Brief

A Phase 3 clinical trial evaluating CYPHER Sirolimus-eluting Coronary Stent for Coronary Artery Disease. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartSep 1, 2003
Primary CompletionNov 1, 2004
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.7 years ago

Interventions

CYPHER Sirolimus-eluting Coronary Stentdevice

2.25 Cypher Sirolimus-eluting Coronary Stent