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.
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Phase I: Number of Participants With Dose-limiting Toxicities
Timeframe: Up to 1 week following percutaneous coronary intervention.
Number of Participants With Procedural Complications
Timeframe: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timeframe: Up to 6 months.
Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month
Timeframe: From the day of Percutaneous Coronary Intervention to 1 Month.
Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months
Timeframe: From the day of Percutaneous Coronary Intervention to Month 6.