Last reviewed · How we verify
NCT06182397: MAGICAL BTK
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
NA trial testing MagicTouch PTA Sirolimus drug coated balloon in Arterial Disease of Legs in 368 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | Concept Medical Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 368 |
| Start date | 16 January 2025 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 February 2031 |
| Sites | 29 locations across United States |
Drugs / interventions tested
- MagicTouch PTA Sirolimus drug coated balloon
- Placebo balloon angioplasty
Conditions studied
- Arterial Disease of Legs — all drugs for Arterial Disease of Legs →
- Below-the-knee Obstruction — all drugs for Below-the-knee Obstruction →
- PAD - Peripheral Arterial Disease — all drugs for PAD - Peripheral Arterial Disease →
Sponsor
Concept Medical Inc.
Who can join
21 and older, any sex, with Arterial Disease of Legs or Below-the-knee Obstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited. The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either: 1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06182397
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Concept Medical Inc. trials
Trials by the same sponsor.
- NCT04562740 — ABLUMINUS DES BTK Registry - FIM · NA · unknown
- NCT04236609 — Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Dis · NA · unknown
- NCT04368091 — Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatmen · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06182397 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Concept Medical Inc.
- Last refreshed: 2 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06182397.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing