# Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

> **NCT06182397** · NA · RECRUITING · sponsor: **Concept Medical Inc.** · enrollment: 368 (estimated)

## Conditions studied

- Arterial Disease of Legs
- Below-the-knee Obstruction
- PAD - Peripheral Arterial Disease

## Interventions

- **DEVICE:** MagicTouch PTA Sirolimus drug coated balloon
- **DEVICE:** Placebo balloon angioplasty

## Key facts

- **NCT ID:** NCT06182397
- **Lead sponsor:** Concept Medical Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-01-16
- **Primary completion:** 2026-12-01
- **Final completion:** 2031-02-01
- **Target enrollment:** 368 (ESTIMATED)
- **Last updated:** 2026-01-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06182397

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06182397, "Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT06182397. Licensed CC0.

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