US-based medical device company C R Bard has announced that its Lutonix In-Stent Restenosis (ISR) clinical trial in the US has enrolled the first patient.
Lutonix ISR clinical trial is a pivotal, randomized Investigational Device Exemption (IDE) trial in the US. The multi-center is designed to compare the safety and efficacy of the Lutonix 035 drug coated balloon PTA catheter to a standard angioplasty balloon for the treatment of femoropopliteal artery in-stent restenosis.
The study is expected to enroll several hundred patients at 30 sites in the US. The enrolled patients will be randomized (2:1) for treatment with a Lutonix DCB (study arm), or a standard non-coated angioplasty balloon (control arm).
Yale – New Haven Hospital Vascular Medicine medical director Dr Carlos Mena, is the principal investigator of the Lutonix ISR clinical trial.
Dr Mena said that with today’s treatment limitations, in-stent restenosis remains difficult to treat.
"I am excited to lead this groundbreaking study and for the potential to provide the medical community a new tool to treat patients with these complex challenges," Dr Mena added.
Lutonix is similar to a traditional angioplasty balloon but is coated with a low dose of paclitaxel. Paclitaxel, an antiproliferative drug with excipients sorbitol and polysorbate, prevents scar tissue from forming around a stent or balloon and also helps keep vessels clear after surgery.
The combination forms a high-integrity coating adhesion intended to be durable enough to stick to the balloon during prep and transit while also allowing release of the drug to the target vessel during 30-second balloon inflation.
Currently, the Lutonix 035 drug coated balloon PTA catheter is being studied in the SFA in Levant 2, a multi-center, randomized US IDE trial. The Lutonix ISR trial is designed to produce long-term clinical evidence of the Lutonix DCB in order to expand treatment options for peripheral arterial disease.
Results from the LEVANT 2 trial has been submitted by Bard to the US Food and Drug Administration and is currently seeking approval of the Lutonix DCB in the US. The Lutonix DCB is commercially available in Europe.