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Peripheral Artery DiseaseLIMESNCT04772300

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

A study testing Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter and Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA) in people with Peripheral Artery Disease, run by Jena University Hospital at 19 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter and Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
19 sitesin 2 countries
Study dates
10 Feb 2022to 17 Nov 2028
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of consent.
  • Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.
  • Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses).
  • Life expectancy > 1 year in the investigator's opinion.
  • Subject presenting with documented chronic limb-threatening ischemia (CLTI) in the target limb defined as Rutherford category 4, 5 or 6.
  • In case of Rutherford category 5 or 6: Subjects with documented infection grade ≤ 2 according to the wound ischemia foot infection (WIfI) classification.
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  • All ischemia grades according to the wound ischemia foot infection (WIfI) classifi-cation are allowed.documented infection grade ≤ 2 according to the wound ischemia foot infection (WIfI) classification.
  • 7. All ischemia grades according to the wound ischemia foot infection (WIfI) classification are allowed.
  • 8. Reference Vessel Diameter (RVD) ≥ 2 and ≤ 4.0 mm. 9. ≥ 75 % stenosis or occlusion of the target vessel by visual estimate of the treating physician; no minimal lesion length required.
  • 10. The target lesion may consist of multiple target vessel lesions, if they are ≤ 5 cm away from each other and if at least one of them is a stenosis ≥ 75 % and all lesions are located in only one of the infrapopliteal arteries or directly within the transition area. Non-target vessels (e.g. inflow lesions or contralateral extremity, other non-target vessels below the knee) and non-target lesions of the target ves-sel can be treated during the study index procedure but according to the patient's randomization result (interventional group: Sirolimus-coated balloon or POBA; control group: only POBA).
  • 11. Lesion length < 30 cm, no limitation in number of used devices. 12. The lesion must be located in the infrapopliteal arteries and above the ankle joint. Lesions may not be located above the tibioperoneal trunk or below the tibiotalar joint (arteries of the foot), nor can the treatment (investigational device or standard PTA, including pre-dilatation) extend beyond these indicated regions for more than 1 cm. Note: A target lesion can extend into the P3 segment in case it involves a straight uninterrupted lesion extending from the target vessel.
  • 13. Presence of documented run-off to the foot (clearly visible at least one of the following run-off vessels: dorsalis pedis or pedal arch or plantar arteries by angiography). The target vessel should give direct or indirect run-off to the foot.
  • 14. Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (≥ 50 % stenosis) can be included if the lesion(s) have been treated successfully before enrollment, with a maximum residual stenosis of ≤ 30 % per visual assessment. If an inflow lesion must be treated within or above the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthy tissue between this (treated) lesion and the infrapopliteal target lesion. Use of paclitaxel-coated devices is not permitted.
  • 15. Successful pre-dilatation of the (entire) target lesion. Success being documented by angiographic visual estimate of ≤ 50 % residual diameter stenosis of the target lesion and no flow limiting dissection (< Grade D dissection).
  • 16. Participants can only be enrolled once with a single target lesion.

Who cannot join

  • Subjects with major amputation of the target leg above the ankle joint.
  • Planned index limb major amputation above the ankle joint, or any other planned major surgery within 30 days pre- or post-procedure. A planned amputation includ-ing and below the ankle is accepted.
  • Recent MI or stroke < 30 days prior to the index procedure.
  • Any vascular treatment with any drug-coated devices 4 weeks prior to index procedure
  • Known or suspected active infection at the time of the index procedure (abnormal white blood cell count, fever, sepsis or positive blood culture), excluding an infection of a lower extremity wound on the target limb (corresponding to WIfI infection grad 3)
  • Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation regarding the study leg; Subjects with uncomplicated ulcers can be included.
Show all 22Show fewer
  • Subjects with documented active osteomyelitis of the study leg, excluding the phalanges and metatarsalia, that is beyond cortical involvement of the bone per clinical judgment
  • Subjects with systemic vasculitis, such as Lupus Erythematosus or polymyalgia rheumatica on active treatment.
  • Subjects receiving systemic corticosteroid therapy (expected dosage > 5 mg of prednisolone or equivalent, per day, during the initial 9 months after procedure) or other systemic immunosuppressant therapy.
  • Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies which could not be substituted, and/or sirolimus or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
  • The subject is currently enrolled in another investigational device, drug or biological trial.
  • Female subjects who are breast feeding at the time of enrollment
  • Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
  • Prior stent(s) or bypass surgery with safety margin < 3 cm within the target vessel (including stents placed within target vessels during the index procedure prior to randomization).
  • Previous procedure with drug-coated balloons in the target vessel within 6 months prior to index procedure.
  • Stenosis ≥ 75 % or occlusions (target lesion) located or extending in the popliteal artery or below the ankle joint space. Note: A target lesion can extend into the P3 segment in case it involves a straight lesion extending from the target vessel. Non-significant stenosis below the ankle joint can be allowed in case this is not part of the target lesion.
  • Untreated significant (≥ 50 % residual stenosis measured by Duplex Sonography) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries.
  • Failure to obtain a ≤ 30 % residual stenosis in pre-existing, hemodynamically sig-nificant (≥ 50 % measured by Duplex Sonography) inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
  • Aneurysm in the target vessel.
  • Angiographic evidence of thrombus within target vessel.
  • Pre-dilatation resulted in a major (≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 50 %.
  • Use of alternative therapy, e.g. atherectomy, scoring balloon, laser, radiation therapy, stents as part of target vessel treatment or planned CO2 angiography. Note: Use of stents is only allowed for bailout stenting.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Germany17 sites

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen; Clinic for Cardiology and Angiology II

    Bad Krozingen, 79189

  • Heart and Diabetes Center North Rhine Westphalia, Clinic for General and Interventional Cardiology/Angiology

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Universitätsklinikum Brandenburg, Abteilung für Innere Medizin 1, Hochschulklinik für Angiologie

    Brandenburg, 14770

  • Sana Kliniken Oberfranken Coburg

    Coburg, 96450

  • DIAKO gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie

    Flensburg, 24939

  • Universitätsklinikum Hamburg-Eppendorf, Universitäres Herz- und Gefäßzentrum Hamburg, Klinik und Poliklinik für Gefäßmedizin

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie

    Heidelberg, 69120

  • Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie

    Jena, 07747

  • University Hospital Leipzig

    Leipzig, 04103

  • Bonifatius-Hospital Lingen (Ems)

    Lingen, 49808

  • Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie

    Münster, 48149

  • Elblandklinikum Radebeul, Gefäßzentrum

    Radebeul, 01445

  • Krankenhaus Barmherzige Brüder Regensburg, Institut für Radiologie, Neuroradiologie und Nuklearmedizin

    Regensburg, 93049

  • Schön Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie

    Rendsburg, 24768

  • Kreiskrankenhaus Torgau

    Torgau, 04860

  • University Hospital Tuebingen, Diagnostic and Interventional Radiology

    Tübingen, Baden-Wurttemberg, 72076

  • GRN Klinik Weinheim, Kardiologie/Angiologie

    Weinheim, 69469

Other trials in Germany

Austria2 sites

  • AKH Wien, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie

    Vienna, 1090

  • Hanusch-Krankenhaus

    Vienna, 1140

Other trials in Austria

About this study

Official title: Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of SiroLIMus Drug Coated Balloon Versus Non-coated Standard Angioplasty for the Treatment of Infrapopliteal Occlusions in Patients With PEripheral Arterial DiSease

This study is a prospective, interventional, multicenter 1:1 randomized trial.

The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.

Read the detailed description

The purpose of this study is to assess whether efficacy of the MagicTouch® Sirolimus Coated PTA Balloon Catheter (SRL-DCB) is superior and whether safety is non-inferior to Plain Old Balloon Angioplasty (POBA) regarding treatment of high-grade stenoses ≥ 75 % in the infrapopliteal arteries (located below the P3 segment of the popliteal artery to the tibiotalar joint) in patients presenting with chronic limb-threatening ische-mia (CLTI) (Rutherford 4-6).

Being tested
Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter, Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)
Keywords
Peripheral Artery Disease, Sirolimus, Drug-Coated Balloon, Percuteanous Transluminal Angioplasty, MagicTouch, Below-the-knee, BTK, Drug-Coated Ballon, plain old angioplasty, POBA, Randomized-Controlled Trial
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon CatheterCombination product

    PTA with an sirolimus drug-coated balloon catheter (SRL-DCB) in the infrapopliteal artery

  • Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)Device

    PTA with an non-coated balloon catheter (POBA) in the infrapopliteal artery

Study groups in NCT04772300
Study groupRoleWhat they receive
Sirolimus DCB groupExperimentalIntervention with Sirolimus-coated balloon catheter
Receives: Combination Product: Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter
POBA groupActive comparatorIntervention with non-coated balloon catheter (POBA)
Receives: Device: Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)

What is being measured

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

  1. composite of limb salvage and primary patency at 6 months

    composite of limb salvage and primary patency at 6 months. Primary patency is defined as absence of target lesion restenosis ≥ 75 % or re-occlusion (corresponding to PSVR > 3.5 or no flow)as determined by duplex ultrasound without clinically driven target lesion revascularization (CD-TLR) after index procedure.

    Clinically driven TLR is defined as revascularization due to restenosis of ≥ 50 % in the target lesion and

    • Deterioration of Rutherford Class and/or
    • Deterioration or persistence of wounds according to the WIfI classification wound component score

    Measured: 6 months after study procedure (PTA with medical product under investigation or comparator)

Secondary outcomes (31)

  1. MALE-POD

    Major Adverse Limb Events (MALE) with perioperative all-cause death (POD) at 30 days Major Adverse Limb Events (MALE) are defined as above-ankle amputation or major reintervention (i.e., new bypass graft, interposition graft revision, or thrombectomy/thrombolysis) of the treated limb involving a BTK artery.

    Perioperative death (POD) is defined as death within 30 days after index proce-dure.

    Major Adverse Limb Events (MALE) are defined as above-ankle amputation or major reintervention (i.e., new bypass graft, interposition graft revision, or thrombectomy/thrombolysis) of the treated limb involving a BTK artery.

    Perioperative death (POD) is defined as death within 30 days after index procedure.

    Measured: 30 days after study procedure.

  2. rate of clinically-driven TVR

    occurrence of clinically-driven TVR at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  3. TVR rate in treated target vessel and non-target vessels

    Rate of all TVR including treated non-target vessel at 1, 6, 12, 24 and 36 months.

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  4. TVR rate

    Rate of all TVR at 1, 6, 12, 24 and 36 months.

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  5. Primary Patency rate

    Primary Patency rate at certain time points

    Measured: 1, 6, 24 and 36 months after study procedure.

  6. Primary Patency of target and treat non-target vessel

    Primary Patency rate of target and treat non-target vessel at certain time points

    Measured: 1, 6, 24 and 36 months after study procedure.

  7. Secondary Patency rate

    Secondary Patency rate at certain time points

    Measured: 1, 6, 24 and 36 months after study procedure.

  8. Secondary Patency of target and treat non-target vessel

    Secondary Patency rate of target and treat non-target vessel at certain time points

    Measured: 1, 6, 24 and 36 months after study procedure.

  9. Re-stenosis of >= 75% or occlusion rate

    Rate of re-stenosis or re-occlusion at certain time points, defined as the absence of flow in the target vessel as determined by duplex ultrasound

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  10. Number of treated Non-target vessels

    Number of treated Non-target vessels

    Measured: 36 months after study procedure

  11. Walking Capacity Assessment 1

    patient-self-assessment of walking distance at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  12. Walking Capacity Assessment 2

    VascuQoL questionnaire (Vascular Quality of Life Questionnaire) at certain time points; 25 questions (scale 1 to 7); best score 175, worst score 25.

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  13. Target Limb Major Amputations

    Rate of target limb major amputations at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  14. all-cause mortality

    Rate of all-cause death at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  15. Amputation free survival (AFS)

    Amputation free survival (AFS) at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  16. Amputation free survival and resolved CLTI

    Amputation free survival and resolved CLTI at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  17. Ankle-Brachial-Index (ABI)

    Change in ankle-brachial index (ABI) from pre-procedure to certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  18. Toe-Brachial-Index (TBI)

    Change in toe-brachial index (TBI) from pre-procedure to certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  19. Rutherford classification

    Change in Rutherford category from pre-procedure to certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  20. Primary sustained clinical improvement

    improvement shift in the Rutherford Category of one class or more in amputation free surviving patients without the need for clinically driven TVR at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  21. Secondary sustained clinical improvement

    improvement shift in the Rutherford classification of one class or more in amputation free surviving patients including those with clinically driven TVR at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  22. EQ-5D-3L

    Change in EQ-5D-3L (Quality of Life questionnaire) from pre-procedure to certain time points; 5 questions (scale 1 to 3), best score 5, worst score 15.

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  23. Wound healing

    Rate of wound healing from pre-procedure to certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  24. New or recurrent wound of the target limb

    New or recurrent wound of the target limb from pre-procedure to certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  25. Length of in-hospital-stay

    Days of hospitalization at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  26. Major Adverse Limb Events (MALE)

    MALE at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  27. Device Success

    Device Success defined as exact deployment of the device according to the instructions for use

    Measured: at index procedure

  28. Technical Success

    Technical success defined as successful vascular access and completion of the endovascular procedure with <= 50% residual diameter stenosis and restoration of in-line flow to the ankle

    Measured: at index procedure

  29. Procedural success

    1. Procedural success, defined as combination of technical success, device suc-cess and absence of major adverse events (MALE-POD, myocardial infarction, stroke) within 72 h of the index procedure).

    Measured: at index procedure

  30. composite endpoint: patency, rate of overall-cause death and amputation-free survival

    composite endpoint consisting of patency, rate of overall-cause death and amputation-free survival at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

  31. composite endpoint: rate of all-cause death, target limb major amputation and clinically-driven TLR

    composite endpoint consisting of rate of all-cause death, target limb major amputation and clinically-driven Target Lesion Revascularization at certain time points

    Measured: 1, 6, 12, 24 and 36 months after study procedure.

Timeline

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

  1. First posted26 Feb 2021
  2. Study start10 Feb 2022
  3. Primary completion17 Apr 2026 (estimated)
  4. Study completion17 Nov 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1-randomization, parallel design, stratified by center.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772300
Sponsor's protocol ID
ZKSJ0132
Acronym
LIMES
Status last verified
Dec 2025
First submitted
23 Feb 2021
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teichgraber U, Platzer S, Lehmann T, Ingwersen M, Aschenbach R, Beschorner U, Scheinert D, Zeller T. Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study. Cardiovasc Intervent Radiol. 2022 Nov;45(11):1716-1724. doi: 10.1007/s00270-022-03213-z. Epub 2022 Jul 29.

    PubMed 35906491

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter and Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA) in people with Peripheral Artery Disease, run by Jena University Hospital at 19 sites in 2 countries.

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 15 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite of limb salvage and primary patency at 6 months (time frame: 6 months after study procedure (PTA with medical product under investigation or comparator)). 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 NCT04772300, which also lists 1 linked publication.

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 26 Dec 2025.

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