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Acotec DCB Post Market Clinical Follow-up
Sponsor: Acotec Scientific Co., Ltd
Summary
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6
Official title: All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2020-06-04
Completion Date
2027-03-01
Last Updated
2024-08-01
Healthy Volunteers
No
Conditions
Interventions
AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment
Locations (7)
Halle
Halle, Saxony-Anhalt, Germany
Eilenburg
Eilenburg, Germany
Department of Angiology, University Hospital Leipzig,
Leipzig, Germany
Elblandklinikum Radebeul
Radebeul, Germany
Elblandklinikum Radebeul
Riesa, Germany
REGIOMED Klinikum Sonneberg
Sonneberg, Germany
KKH Torgau
Torgau, Germany