The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)

Not Applicable

• Conditions: Femoropopliteal artery disease

• Registration Number: JPRN-UMIN000033747
• Lead Sponsor: Medicon Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-14
• Study Completion: 2021-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

NA

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency at 6 and 12 months post procedure

Secondary Outcome Measures

Name	Time	Method
- Target Limb Reintervention, unscheduled target limb amputation and target limb related death during the follow-up period - SAE during the follow-up period, which the relation to device or procedure cannot be denied - Device malfunction and adverse event during the follow-up period which the relation to device or procedure cannot be denied - Freedom from clinically-driven (including ABI, Rutherford Classification) TLR at 1 month, 6 months and 12 months post procedure - Duration of Lutonix DCB related DAPT at pre-procedure and during follow-up period