NCT00124943

Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis (ISR) lesions.

Conditions

• Coronary Restenosis

Interventions

Type	Name	Description
DRUG	Nanoparticle Paclitaxel	Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2005-07-29
• Last updated: 2012-04-02
• Results posted: 2012-03-08