Phase II, double-blind,
placebo-controlled, regimen finding study
Dose: 30 mg/kg (MTD from CAD
Phase I)
Route: Bilateral
intra-arterial, days 1 and 30
Groups: Placebo, SINGLE,
DOUBLE
Primary Endpoint: change in PWT at Day 90
Secondary Endpoints:
PWT at 180 days
QOL at 90 and 180 days
COT and ABI at 90 and 180 days