# Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty

> **NCT04238546** · NA · ACTIVE_NOT_RECRUITING · sponsor: **Nils Kucher** · enrollment: 1200 (estimated)

## Conditions studied

- Peripheral Arterial Disease

## Interventions

- **DEVICE:** sirolimus-coated balloon catheter
- **DEVICE:** uncoated balloon catheter

## Key facts

- **NCT ID:** NCT04238546
- **Lead sponsor:** Nils Kucher
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-11-03
- **Primary completion:** 2025-12-31
- **Final completion:** 2029-12-31
- **Target enrollment:** 1200 (ESTIMATED)
- **Last updated:** 2026-02-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04238546

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04238546, "Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04238546. Licensed CC0.

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