Evaluation of stent angioplasty as a therapeutic option in the treatment of arteriosclerotic lesions of the common femoral artery.

• Conditions: I70.20

• Registration Number: DRKS00024584
• Lead Sponsor: niversitäts-Herzzentrum Bad Krozingen

Brief Summary

A total of 236 interventions (94.4%) were successfully defined as a residual stenosis < 30%. Periinterventionally, there were 23 complications (9.1%), 3 of which had to be treated surgically. Median follow up was 21 months (average 19.2 ± 7.8). In total, 41 patients (16.4%) needed a TLR. The primary patency rate was 90.8%, 81.2% and 72% at 6, 12 and 24 months, respectively. ABI and RBC were significantly better at all time points compared to baseline. During follow up, seven amputations (three minor and four major) had to be performed. More than half of the patients (56.0%) were punctured at the stented CFA during the follow up. Multivariate logistic regression analysis showed continued nicotine use and coronary heart disease as predictors for TLR.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Study Completion: 2022-02-01
• Results First Posted: 2022-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Clinical stage IIa-IV according to Fontaine/ 2-5 Rutherford-Becker.
Angiography: Arteriosclerotic stenosis (> 70% diameter reduction) or occlusion of the femoral artery.

Exclusion Criteria

No stent angioplasty in the common femoral artery

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of target lesion revascularization (TLR) at the target lesion.

Secondary Outcome Measures

Name	Time	Method
Time to first reintervention at target lesion (TLR).<br>Rate of TLR at 12 and 24 months.<br>Primary and secondary patency rates of the target lesion 12 and 24 months after the index procedure.<br>Rate of minor and major amputations on the treated leg 12 and 24 months after the index procedure.<br>Leg preservation rate at 12 and 24 months.<br>Clinical improvement using the Rutherford-Becker classification (see Appendix).<br>Serious cardiovascular events (myocardial infarction, stroke, major amputation, death) 12 and 24 months after the index procedure.<br>Number of ipsilateral punctures of the common femoral artery.