# Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

> **NCT04772300** · NA · ACTIVE_NOT_RECRUITING · sponsor: **Jena University Hospital** · enrollment: 230 (estimated)

## Conditions studied

- Peripheral Artery Disease

## Interventions

- **COMBINATION_PRODUCT:** Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter
- **DEVICE:** Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)

## Key facts

- **NCT ID:** NCT04772300
- **Lead sponsor:** Jena University Hospital
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-02-10
- **Primary completion:** 2026-04-17
- **Final completion:** 2028-11-17
- **Target enrollment:** 230 (ESTIMATED)
- **Last updated:** 2025-12-26

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04772300

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04772300, "Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease". Retrieved via AI Analytics 2026-09-08 from https://api.ai-analytics.org/clinical/NCT04772300. Licensed CC0.

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