Study ID: ILLUMENATE BTK
Prospective, multicenter study to evaluate treatment of subjects with occlusive disease in below-the-knee arteries, with a novel paclitaxel-coated angioplasty balloon: a post-market clinical study.
This randomized study is testing the safety and effectiveness of the drug-coated Stellarex™ angioplasty balloon for treatment of arterial lesions vs. traditional balloon angioplasty.
All patients in the trial undergo angioplasty with either the Stellarex drug-coated balloon or a traditional angioplasty balloon. Patients then undergo follow-up care in the clinic at 30 days, and three, six, 12, 24 and 36 months. Phone follow up continues at 48 months and 60 months.
Certain patients in the study also are enrolled in the Vessel Preparation Registry. These patients are treated first with the Turbo Elite™ Laser for added vessel preparation, followed by treatment with the Stellarex balloon.
This multicenter, randomized, post-market clinical trial is testing the Stellarex™ 0.014ʺ OTW drug-coated angioplasty balloon for treatment of BTK lesions (located in the popliteal artery below the knee through the infrapopliteal vessels to the tibiotalar joint) vs. a traditional angioplasty catheter. Patients are randomized 2:1 to receive treatment with the Stellarex balloon or a traditional balloon.
Eligible patients must have critical limb ischemia, Rutherford-Becker classification of 4 or 5. The reference vessel diameter must be ≥2 - ≤4mm. At least one target lesion must be ≥6 cm in length. Other inclusion/exclusion criteria apply.
This study also has a registry component: The Vessel Preparation Registry includes subjects who demonstrate a non-crossable lesion(s) by a guidewire or lesion(s) that cannot be successfully pre-dilated. For those patients, the Turbo Elite™ Laser will be used for vessel preparation, followed by treatment with the Stellarex™ balloon.
- Must have been diagnosed with lesions of the popliteal or infrapopliteal arteries
- Must be willing to undergo all follow-up care