NCT06271590 (MAGICAL SV) is a NA clinical trial of Sirolimus Drug Coated Balloon in Coronary Artery Disease, sponsored by Concept Medical Inc..

Who is sponsoring NCT06271590?

NCT06271590 is sponsored by Concept Medical Inc..

What drugs are being tested in NCT06271590?

Interventions in NCT06271590: Sirolimus Drug Coated Balloon, Drug eluting stents (DES).

What condition does NCT06271590 study?

NCT06271590 studies Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases.

Is NCT06271590 still recruiting?

NCT06271590 is currently recruiting now. Last updated 4 September 2025.

Last reviewed 2025-09-04 · How we verify

NCT06271590: MAGICAL SV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The MAGICAL SV Trial - A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients With Coronary Artery Disease.

Recruiting now NA Last updated 4 September 2025

What this trial tests

NA trial testing Sirolimus Drug Coated Balloon in Coronary Artery Disease in 1,605 participants. Currently enrolling.

Timeline

20 May 2025

Primary endpoint
1 November 2028

1 November 2031

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	1,605
Start date	20 May 2025
Primary completion	1 November 2028
Estimated completion	1 November 2031
Sites	24 locations across United States

Drugs / interventions tested

Sirolimus Drug Coated Balloon
Drug eluting stents (DES)

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →
Native Coronary Artery Stenosis — all drugs for Native Coronary Artery Stenosis →
Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Concept Medical Inc.

Who can join

Adults 18 to 80, any sex, with Coronary Artery Disease or Native Coronary Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Target lesion failure (TLF)
Time frame: within 12 months
the composite of cardiovascular mortality, target-vessel myocardial infarction (TV-MI) and ischemia driven target lesion revascularization

Sponsor's own description

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Expanding the role of drug-coated balloons in native large coronary artery disease.
Colombo A, Leone PP. · · 2026 · PMID 42087864 · DOI 10.24875/recice.m25000542

Verify or expand the search:

Other trials of Sirolimus Drug Coated Balloon

Trials testing the same drug.

NCT05333640 — A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatm · unknown

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting

Other Concept Medical Inc. trials

Trials by the same sponsor.

NCT06182397 — Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease · NA · recruiting
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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06271590 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 4 September 2025

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/NCT06271590.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing