Clinical Trials Detalhe
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Visão Geral
Gender
ALL
Idade
N/A
Fase
N/D
Tipo de Estudo
OBSERVATIONAL
Localização
Hospital Santa Marta (C.H.Lisboa Central) (Lisboa, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT02554266Sumário
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.
Condições
Peripheral Artery Disease
Elegibilidade
Inclusion Criteria: 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 Instructions for Use (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. Exclusion Criteria: 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).