ong-term follow up and mortality rate of patients of the randomized Freeway Stent Study

• Conditions: PERIPHERAL ARTERIAL DISEASE (PAD); I70.2; Atherosclerosis of arteries of extremities

• Registration Number: DRKS00025135
• Lead Sponsor: Eurocor Tech GmbH

Brief Summary

o increased late mortality was observed at 5 years, with an all-cause mortality rate of 12.0% in the FREEWAY drug-eluting balloon group versus 15.0% in the non-paclitaxel PTA group. No accumulation of any cause of death was observed in either group, nor was there any correlation with the dose of paclitaxel used. Freedom from clinically driven target lesion revascularization at 5 years was significantly higher in the FREEWAY drug eluting balloon group (85.3%) compared to standard PTA group (72.7%) Log-rank p = 0.032.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-08
• Study Completion: 2023-03-15
• Results First Posted: 2024-01-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients that were included in the Freeway Stent Study.

Exclusion Criteria

Inclusion only of Patients that participated in the Freeway Stent Study.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality rate at 5 years after inclusion in the Freeway Stent Study.

Secondary Outcome Measures

Name	Time	Method
Mortality rate 2-4 years <br>Revascularization rate 2-5 years <br>SAE 2-5 years