Popliteal Artery DiseasePhase 2/3MAGICAL SFANCT07359807

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

A Phase 2/3 study testing Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter and Paclitaxel drug-coated balloon angioplasty in people with Popliteal Artery Disease and Superficial Femoral Artery Disease, run by Concept Medical Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Popliteal Artery Disease, Superficial Femoral Artery Disease
What is being tested?: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter and Paclitaxel drug-coated balloon angioplasty
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 478 participants
Where: No sites listed yet
Study dates: Apr 2026to Jan 2033
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Farhana Siddique contact

332-273-2727

farhana@conceptmedical.com

About this study

Official title: 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.

Conditions: Popliteal Artery Disease, Superficial Femoral Artery Disease
Being tested: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
Keywords: SFA, Sirolimus, Paclitaxel, Drug-eluting, Angioplasty, Balloon, MagicTouch, PAD, Peripheral Arterial Disease, Stenotic, Stenosis, Occlusion, Superfical Femoral Artery, Popliteal Artery
Medical subject headings: Peripheral Arterial Disease, Constriction, Pathologic, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheterCombination product
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.
Paclitaxel drug-coated balloon angioplastyCombination product
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.

Study groups in NCT07359807
Study group	Role	What they receive
MagicTouch sirolimus drug coated angioplasty balloon	Experimental	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. Receives: Combination Product: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter
Paclitaxel drug coated angioplasty balloon	Active comparator	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. Receives: Combination Product: Paclitaxel drug-coated balloon angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: One year from index procedure

Secondary outcomes (1)

Long-term Safety and Efficacy of the Treated Vessel
1. Vesel patency at 6, 12, 24, and 48-month \& free of clinically-driven TLR at 1, 6, 12, 24, 36, 48, and 60-month
2. 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
3. Change in walking capacity assessment from pre-procedure to the respective follow-up visits
4. 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
5. Hemodynamic improvement is defined as an increase in resting ankle brachial index (ABI) from pre-procedure to discharge, 6, 12, 24, and 48-months
6. Change in quality-of-life (QoL) assessment by VascuQol questionnaire and EQ5D-5L index questionnaire from pre-procedure through applicable follow-up visits
7. All-cause mortality at 1, 6, 12, 24, 36, 48, and 60-month
8. Target limb major amputation at 1, 6, 12, 24, 36, 48, and 60-month
Measured: Up to five years after index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2026Jan 2033

First posted22 Jan 2026
Study startApr 2026 (estimated)
Primary completionDec 2027 (estimated)
Study completionJan 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Popliteal Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 478 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07359807
Sponsor's protocol ID: CM-US-R06
Acronym: MAGICAL SFA
Status last verified: Jan 2026
First submitted: 21 Jan 2026
Last updated: 17 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No: This may change, but at this time, the results are for potential future marketing and sales of the investigational device pending government approval.

Interested in taking part?

Farhana Siddique

332-273-2727

farhana@conceptmedical.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Active, not recruiting
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Not yet recruitingObservational study
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
Popliteal Artery Entrapment Syndrome
Active, not recruitingObservational study
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis

All Popliteal Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MAGICTouchTM PTA Sirolimus-Coated BALloon vs Paclitaxel Coated Balloon for Treatment of High-grade Stenotic or Occluded Lesions in Femoro-Popliteal Arteries
ClinicalTrials.gov ID: NCT07359807
Acronym / sponsor ID: MAGICAL SFA / CM-US-R06
Conditions: Popliteal Artery Disease, Superficial Femoral Artery Disease
Keywords: SFA, Sirolimus, Paclitaxel, Drug-eluting, Angioplasty, Balloon, MagicTouch, PAD
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 478 participants (estimated)
Lead sponsor: Concept Medical Inc.Industry (pharma, biotech, devices)
Study start: Apr 2026 (estimated)
Primary completion: Dec 2027 (estimated)
Study completion: Jan 2033 (estimated)
First posted: 22 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MagicTouch sirolimus drug coated angioplasty balloon	Experimental	Combination Product: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheterSubjects randomized to this arm will receive the experimental device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
Paclitaxel drug coated angioplasty balloon	Active comparator	Combination Product: Paclitaxel drug-coated balloon angioplastySubjects randomized to this arm will receive the control device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheterSirolimus 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.	Combination product	MagicTouch sirolimus drug coated angioplasty balloon
Paclitaxel drug-coated balloon angioplastyPaclitaxel, 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.	Combination product	Paclitaxel drug coated angioplasty balloon

Primary outcome

Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
Time frame: One year from index procedure
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

1 secondary outcome

Long-term Safety and Efficacy of the Treated Vessel
Time frame: Up to five years after index procedure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Individual participant dataSharing planned: No. This may change, but at this time, the results are for potential future marketing and sales of the investigational device pending government approval.

Related trials for Popliteal Artery Disease

Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Active, not recruiting
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Not yet recruitingObservational study
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
Popliteal Artery Entrapment Syndrome
Active, not recruitingObservational study
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Farhana Siddique contact

332-273-2727

farhana@conceptmedical.com

Farhana Siddique study director

Concept Medical Inc.

Sahil Parikh, MD principal investigator

New York-Presbyterian/Columbia University Hospital

Eric A Secemsky, MD principal investigator

Beth Israel Deaconess Medical Center

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Farhana Siddique (332-273-2727, farhana@conceptmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months) (time frame: One year from index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07359807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.