A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries. (MAGICAL SFA)

MAGICTouchTM PTA Sirolimus-Coated BALloon vs Paclitaxel Coated Balloon for Treatment of High-grade Stenotic or Occluded Lesions in Femoro-Popliteal Arteries

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Superficial Femoral Artery Disease; Popliteal Artery Disease
• Intervention / Treatment: Combination product: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter; Combination product: Paclitaxel drug-coated balloon angioplasty

• Study Type: Interventional
• Enrollment (Estimated): 478
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Farhana Siddique; Phone Number: 332-273-2727; Email: farhana@conceptmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject age ≥ 21 years
• Subject has been informed of the nature of the trial, the duration of the trial, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
• Rutherford category 2-4 according to the investigator's subjective evaluation
• Subject has de-novo or re-stenosed lesion with ≥ 70% stenosis documented angiographically, and no prior stent in the target lesion.
• Target lesion length is ≥ 40mm and ≤ 200mm by visual estimate of the treating physician.
• Multiple lesions with max. A 30mm healthy vessel segment between lesions can be considered, at the treating physician's discretion, as one lesion. Total lesion length should not exceed 200mm.
• Reference vessel diameter (RVD) ≥ 4mm and ≤ 7 mm by visual estimation.
• Patency of P2 and P3 segments of the popliteal artery and at least one (1) infra-popliteal artery to the ankle (< 50% diameter stenosis) in continuity with the femoropopliteal artery.
• Patency of the ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis > 30% may be treated during the index procedure to ensure sufficient inflow.
• Staged Intervention of the contralateral limb is permitted at +/- 30 days.
• A subject can only be enrolled and randomized once with only one target lesion in the MAGICAL SFA trial. Note that only the lesion in one limb can be treated as a target lesion for the index procedure.

Exclusion Criteria:

• Failure of the guidewire to successfully cross the target lesion or subintimal target lesion.
• Flow-limiting dissection after pre-dilatation and/or residual stenosis > 30% prior to randomization.
• Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel).
• Presence of fresh/organized thrombus in the target lesion.
• Presence of aneurysm in the target vessel/s.
• Prior vascular surgery (including atherectomy , bypass surgery) of the target limb.
• Prior stent in the target lesion.
• Stroke or heart attack within three months prior to enrollment.
• Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure.
• Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to the index procedure.
• Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, and/or cryoplasty brachytherapy re- entry devices.
• Enrolled in another investigational drug, device, or biologic trial where the primary end point is not yet achieved.
• Life expectancy of less than one year in the investigator's opinion.
• Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, sirolimus, paclitaxel, or contrast media that cannot be adequately pre- treated prior to index procedure.
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Receiving dialysis or immunosuppressant therapy . (A systemic corticosteroid therapy with expected maximum dosage of 5mg prednisolone or equivalent, per day, during the initial 9 months after procedure, is allowed.)
• Subjects with severe (Stage 4) renal disease, defined as eGFR < 30%.
• Pregnant or lactating females .
• History of major amputation in the target lesion limb.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MagicTouch sirolimus drug coated angioplasty balloon; 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.	Combination product: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter; 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.
Active Comparator: Paclitaxel drug coated angioplasty balloon; 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.	Combination product: Paclitaxel drug-coated balloon angioplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Safety and Efficacy of the Treated Vessel	Vesel patency at 6, 12, 24, and 48-month & free of clinically-driven TLR at 1, 6, 12, 24, 36, 48, and 60-month; Sustained clinical improvement: an improvement shift in the Rutherford classification of at least one category in amputation and TVR-free surviving subjects at 12 months; Change in walking capacity assessment from pre-procedure to the respective follow-up visits; Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion post-procedure and at 6, 12, & 24-months, or at any time of re-intervention; Hemodynamic improvement is defined as an increase in resting ankle brachial index (ABI) from pre-procedure to discharge, 6, 12, 24, and 48-months; Change in quality-of-life (QoL) assessment by VascuQol questionnaire and EQ5D-5L index questionnaire from pre-procedure through applicable follow-up visits; All-cause mortality at 1, 6, 12, 24, 36, 48, and 60-month; Target limb major amputation at 1, 6, 12, 24, 36, 48, and 60-month	Up to five years after index procedure

Collaborators and Investigators

• Sponsor: Concept Medical Inc.
• Investigators: Principal Investigator: Eric A Secemsky, MD, Beth Israel Deaconess Medical Center; Study Director: Farhana Siddique, Concept Medical Inc.; Principal Investigator: Sahil Parikh, MD, New York-Presbyterian/Columbia University Hospital; Principal Investigator: Brain DeRubertis, MD, New York Presbyterian - Weill Cornell Medical Center; Principal Investigator: Edward Choke, PhD, Sengkang General Hospital; Principal Investigator: Masahiko Fujihara, MD, Kishiwada Tokushukai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PAD; Occlusion; Stenosis; Angioplasty; Sirolimus; Paclitaxel; Peripheral Arterial Disease; SFA; MagicTouch; Balloon; Popliteal Artery; Drug-eluting; Stenotic; Superfical Femoral Artery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathological Conditions, Anatomical; Chemically-Induced Disorders; Poisoning; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Constriction, Pathologic; Bites and Stings; Peripheral Arterial Disease; Organic Chemicals; Macrolides; Lactones; Sirolimus
• Other Study ID Numbers: CM-US-R06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This may change, but at this time, the results are for potential future marketing and sales of the investigational device pending government approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes