SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
A legfontosabb adatok
- Hol
- Birmingham, Leesburg, Panama City, Raleigh és Torrance (Egyesült Államok)Mind a 5 helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of Alabama MedicineBirmingham, Egyesült ÁllamokNo longer taking part
- IR CentersLeesburg, Egyesült ÁllamokNo longer taking part
- Advanced Vascular InstitutePanama City, Egyesült ÁllamokNo longer taking part
- IR CentersRaleigh, Egyesült ÁllamokNo longer taking part
- Harbor-UCLA Medical CenterTorrance, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- CrannMed
- Azonosító
- NCT06550024
- A regiszteradat frissítve
- 2026. október 30.
- Eredeti leírás
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).A teljes eredeti leírásKevesebb
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Bevonási feltételek: Subject is able and willing to provide written informed consent, and; Clinical diagnosis of knee OA, and; Moderate to severe knee pain (WOMAC Pain ≥ 10), and; Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and; Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and; Age ≥ 40 years and < 80 years, and; Able to comply with all treatments and follow-up visits.
Kizáró feltételek: Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or; Prior knee replacement surgery in the target knee, or; Prior iodinated contrast reaction resulting in anaphylaxis, or; Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or; Current infection of target joint, or; Rheumatoid or known serologic diagnosis of autoimmune arthritis, or; History of uncorrectable coagulopathy, or; Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or; Severe knee OA (Kellgren-Lawrence grade 4), or; Life expectancy less than 36 months, or; Pain score of >3 NRS on the non-target knee, or; An acute internal derangement of the target knee, or; Contraindication to MRI, or; At the discretion of the Principal Investigator.