BLADE-PCI Trial (BLADE); PHASE IIB LIPOSOMAL ALENDRONATE STUDY
Status:
Unknown status
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
The main objective of this study is to assess the safety, efficacy and dose response of
LABR-312 administered intravenously at the time of percutaneous coronary intervention (PCI)
with a drug eluting stent in reducing restenosis as measured by Optical Coherence Tomography
(OCT) at 9 months post procedure in patients with diabetes mellitus (DM).
Administration of LABR-312 at the time of PCI will reduce restenosis compared with placebo as
assessed by the OCT endpoint of % neointimal hyperplasia (%NIH) volume at 9 months in
patients with DM.