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Acotec DCB Post Market Clinical Follow-up — FLOWER  

Peripheral Artery Disease Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04393389
Study type Observational
Source Acotec Scientific Co., Ltd
Contact Schmidt Andrej
Phone +49-341-97
Email Andrej.Schmidt@medizin.uni-leipzig.de
Status Recruiting
Phase
Start date June 4, 2020
Completion date March 1, 2027
View Details
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