| Trial name or title |
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below‐the‐Knee (BTK) Arteries (Lutonix BTK Trial) |
| Methods |
Randomized controlled trial |
| Participants |
Country: Europe, Japan, and North America
Setting: 59 hospitals in Europe, USA, Canada, and Japan
Number of participants: 480
Inclusion criteria:
Male or nonpregnant female ≥ 18 years of age Rutherford clinical category 4 or 5 Life expectancy ≥ 1 year Significant stenosis (≥ 70%) A patent inflow artery Target vessel(s) diameter between 2 mm and 4 mm Target vessel(s) reconstitute(s) at or above the ankle
Exclusion criteria:
Pregnant or planning on becoming pregnant History of stroke within 3 months History of MI, thrombolysis, or angina within 30 days of enrolment Prior or planned major amputation Glomerular filtration rate ≤ 30 mL/minute per 1.73 m2 Acute limb ischemia Instent restenosis of target lesion
|
| Interventions |
Uncoated balloon angioplasty device: unspecified
DEB device: Lutonix drug‐coated balloon catheter
Drug used: paclitaxel
Vessels treated: below‐the‐knee arteries |
| Outcomes |
Primary:
Composite of all‐cause death, above‐ankle amputation, or major re‐intervention Freedom from the composite of above‐ankle amputation Freedom from target vessel occlusion and clinically driven target lesion reintervention
Secondary:
Wound healing Primary patency: freedom from occlusion without clinically driven TLR Change in toe and ankle pressures Revascularization performed on all randomized participants who returned with clinical symptoms, and if the participant has a target lesion diameter stenosis ≥ 50% Limb salvage in surviving participants
|
| Starting date |
May 2013 |
| Contact information |
Robert M Jardin, lutonixresearch@crbard.com |
| Notes |
Sponsor: C.R. Bard |
