MAGICAL SFA
MAGICTouchTM PTA Sirolimus-Coated BALloon vs Paclitaxel Coated Balloon for Treatment of High-grade Stenotic or Occluded Lesions in Femoro-Popliteal Arteries
Sponsor study identifier
interventional
478
0 countries
N/A
Study Start
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the femoropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter. The rationale of this trial is based on the hypothesis that the usage of the MagicTouch drug-coated balloon (DCB) is at least equal (non-inferior) with regard to efficacy and safety in comparison with a clinically well-established paclitaxel drug-coated balloon (PTX DCB). The objective of this prospective, randomized, multi-center trial is to compare the Magic Touch® DCB with PTX DCBs for treatment of high-grade stenotic or occluded lesions in supeficial femoral artery (SFA) and/or P1 segment of the popliteal artery in PAD patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 21, 2026
Actual (reported)January 22, 2026
Actual (reported)April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
Measured by the absence of clinically driven target lesion revascularization (CD-TLR) due to symptoms and a drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure or restenosis with PSVR \> 2.4 evaluated by duplex ultrasound. Also, a composite of freedom from device and procedure-related death through 12-months post procedure, as well as freedom from target limb major amputation and clinically driven target vessel revascularization
One year from index procedure
Long-term Safety and Efficacy of the Treated Vessel
Up to five years after index procedure
Subjects randomized to this arm will receive the experimental device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
Subjects randomized to this arm will receive the control device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
Sirolimus is used outside the United States to block cell growth, cell proliferation (especially T-cells), and angiogenesis (new blood vessel formation). This experimental device uses proprietary technology to adhere sirolimus to the balloon catheter, deliver it to the affected vessel, and ultimately be absorbed by the surrounding tissue.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Device product
Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter
The registry describes a device or delivery product. Its exact ingredients and actual exposure require separate evidence.
View registry recordDevice product
Paclitaxel drug-coated balloon angioplasty
The registry describes a device or delivery product. Its exact ingredients and actual exposure require separate evidence.
View registry recordFarhana Siddique
Concept Medical Inc.
Sahil Parikh, MD
New York-Presbyterian/Columbia University Hospital
Eric A Secemsky, MD
Beth Israel Deaconess Medical Center
Brain DeRubertis, MD
New York Presbyterian - Weill Cornell Medical Center
First Submitted
January 21, 2026
First Posted
January 22, 2026
Study Start
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Paclitaxel, which is used in cancer chemotherapy for various indications, is a drug that disrupts normal microtubule function and prevents neointimal hyperplasia by inhibiting smooth muscle cell migration, proliferation, and extracellular matrix secretion and is currently used in the United States.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Edward Choke, PhD
Sengkang General Hospital
Masahiko Fujihara, MD
Kishiwada Tokushukai Hospital
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 17, 2026
Record last verified: 2026-01
This may change, but at this time, the results are for potential future marketing and sales of the investigational device pending government approval.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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