Midterm results of directional atherectomy for treatment of atherosclerotic common femoral artery lesions

• Conditions: I70.2; Atherosclerosis of arteries of extremities

• Registration Number: DRKS00012497
• Lead Sponsor: niversitäts-Herzzentrum Freiburg-Bad Krozingen

Brief Summary

This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR.

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-05-28
• Study Start: 2017-05-31
• Results First Posted: 2020-05-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

Patients who were treated with atherectomy in the common femoral artery in January 2009-January 2017 and fulfilled the following criteria:
Clinical relevant claudication according to Rutherford-Becker classification in the stadium 2 to 5 or to the Fontaine classification in the stadium of IIa to V.
Angiography: Arteriosclerotic stenosis (> 70% diameter reduction) or obstruction of the common femoral artery

Exclusion Criteria

no atherectomy in the common femoral artery

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: the incidence of target lesion revascularization. <br>

Secondary Outcome Measures

Name	Time	Method
Periinterventional complications, time to target lesion revascularization, primary and secondary patency of the target lesion, major or minor amputation of the target limb, limb salvage rates, change in Rutherford-Becker class, serious cardiovascular events (myocardial infarction, stroke, death)<br>