Influence of the cutting balloon and drug-coated balloon angioplasty on the acute and long-term outcome of endovascular shunt interventions

Recruiting

• Conditions: T82.4; Mechanical complication of vascular dialysis catheter

• Registration Number: DRKS00023295
• Lead Sponsor: niversitäts-Herzzentrum Bad Krozingen

Brief Summary

Between 2010 and 2018, 1125 dialysis patients were treated with iliac and/or femoropopliteal and/or infrapopliteal lesions. In all, 359 patients were selected for this retrospective analysis. Of those, 122 patients were treated with uncoated devices without crossover to a PTX-coated device during follow-up and 237 patients were treated with a PTX-coated device. Mean follow-up time was 27.38±24.76 months (range=0–103). For the entire cohort, the overall mortality was 95.1% after uncoated treatment and 75.9% after PTX treatment (p<0.001). After propensity score matching (n=119), overall mortality was 95.0% after uncoated treatment and 78.2% after PTX treatment (p<0.001). For the entire cohort, multivariate logistic regression analysis revealed age (p=0.002) and critical limb ischemia (p<0.001) as independent predictors for mortality. PTX treatment was a protective factor for mortality (p<0.001).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• Results First Posted: 2022-09-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients with shunt interventions performed at the University Heart Center (Bad Krozingen site)

Exclusion Criteria

None

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary technical endpoint:<br><br>freedom from target lesion revascularisation (TLR) at 6 months follow-up after the index procedure<br>Primary safety endpoint:<br>all-cause mortality after treatment with a paclitaxel-coated balloon compared to uncoated balloons

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints:<br>freedom from re-intervention at the target lesion (target lesion revascularisation, TLR) after 12 months and until the last follow-up<br>restenosis rate after 6, 12 months and until last follow-up<br>Revascularization-free survival<br>Acute treatment success defined as residual stenosis < 50% and <30<br>Time of index intervention for a new shunt<br>Bail out Stentrate<br>