CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
Nanoparticle Paclitaxeldrug
Likely dose
Nanoparticle paclitaxel administered via intracoronary catheter (specific dose not stated)AI-extracted
Key inclusion· 7
  • ✓Age ≥18 years, male or non-pregnant/non-lactating female
  • ✓Diagnosis of angina pectoris, unstable angina pectoris, or documented silent ischemia
  • ✓Left ventricular ejection fraction ≥30%
  • ✓Successful uncomplicated stenting of up to 2 de novo lesions OR balloon angioplasty of up to 2 ISR lesions (not both)
Key exclusion· 13
  • ✕Target de novo lesion treated with drug-eluting stent
  • ✕Target ISR lesion requires any treatment other than balloon angioplasty
  • ✕Both de novo and ISR lesions present
  • ✕More than 2 lesions treated with PCI or additional lesions anticipated to require treatment within 2 months

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

Search/NCT00124943
NCT00124943Phase 2Completed
CompareCT.gov

A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

Celgene Corporation·interventional·Posted Jul 29, 2005·Updated Apr 2, 2012

In Brief

A Phase 2 clinical trial evaluating Nanoparticle Paclitaxel for Coronary Restenosis. Completed, enrolled 112 participants.

Detailed Summary

The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Restenosis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2005
Enrollment StartJul 1, 2005
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.9 years ago

Interventions

Nanoparticle Paclitaxeldrug

Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.