CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)device
Likely dose
CYPHER NxT sirolimus-eluting stent on BX SONIC over-the-wire delivery system (specific stent size based on lesion characteristics)AI-extracted
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Diagnosis of angina (CCS I-IV, Braunwald B&C I-II) or documented silent ischemia
  • ✓Single de novo target lesion in major native coronary artery
  • ✓Target lesion diameter 2.5-3.5 mm by visual estimate
Key exclusion· 6
  • ✕Q-wave or non-Q-wave MI with CK >2× normal within 24 hours and elevated CK/CK-MB at time of treatment
  • ✕Braunwald Class III B/C unstable angina or peri-infarction angina
  • ✕Significant (>50%) stenosis proximal or distal to target lesion requiring revascularization or impairing runoff
  • ✕Left ventricular ejection fraction ≤25%

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

Search/NCT00231283
NCT00231283Phase 3Completed
CompareCT.gov

A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions

Cordis US Corp.·interventional·Posted Oct 4, 2005·Updated Apr 20, 2010

In Brief

A Phase 3 clinical trial evaluating CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) for Coronary Artery Disease. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) 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 4, 2005
Enrollment StartApr 1, 2004
Study CompletionJul 1, 2005
TodayJul 2, 2026
Posted 20.7 years ago

Interventions

CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)device

CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System