MedPath

Prognosis of biodegradable peripheral vascular stent for iliac artery lesions: observational study

Not Applicable
Conditions
Peripheral artery disease for iliac artery lesions
Registration Number
JPRN-UMIN000044946
Lead Sponsor
Department of Surgery, Keio University School of Medicine
Brief Summary

The 12 month primary patency rate was 88.6% (95% CI, 80.1% to 94.4%), which was lower than the prespecified standard. There were no device or procedure related deaths, major amputation, or distal embolization during the follow up period. The ankle brachial index maintained significant improvement through the 5 year period compared with that at baseline.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

Patients who have offered not to cooperate with this study.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy/Safety outcomes up to 60 months after placement of biodegradable stents (adverse events, device complication, patency rate, presence or absence of re-treatment)
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath