A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries - Lutonix BTK Registry

utonix, Inc.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

试验速览

暂无简介。

•1. Male or non-pregnant, non-breastfeeding female *18 years of age;
•2. Rutherford Clinical Category 3-5;
•3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
•4. Significant stenosis (*70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
•5. Lesion(s) can be treated with available Lutonix® DCB device size matrix per current IFU; and
•6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).
•NOTE: Outflow must be assessed AFTER pre-dilatation
•NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.

•Patients will be excluded if ANY of the following conditions apply:
•1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
•2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
•3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

发起方

utonix, Inc.