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

NCT04772300 | Active Not Recruiting DMC

• 1 other identifier: ZKSJ0132
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 19

Brief 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.

Conditions

Peripheral Artery Disease

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

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (31)

• MALE-POD

  30 days after study procedure.

• rate of clinically-driven TVR

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

• TVR rate in treated target vessel and non-target vessels

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

• TVR rate

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

• Primary Patency rate

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

Study Arms (2)

Sirolimus DCB group

EXPERIMENTAL

Intervention with Sirolimus-coated balloon catheter

Combination Product: Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter

POBA group

ACTIVE COMPARATOR

Intervention with non-coated balloon catheter (POBA)

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

Interventions

Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter COMBINATION_PRODUCT

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

Sirolimus DCB group

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

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

POBA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• \. All ischemia grades according to the wound ischemia foot infection (WIfI) classification are allowed.
• \. 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.
• \. 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).
• \. 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.
• \. 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.
• \. 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.
• \. 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).
• \. Participants can only be enrolled once with a single target lesion.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jena University Hospital: lead
• Concept Medical Inc.: collaborator
• Vascuscience: collaborator
• CoreLab Black Forest: collaborator
• Center for Clinical Studies Jena: collaborator

Study Sites (19)

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

Vienna, 1090, Austria

Location

Hanusch-Krankenhaus

Vienna, 1140, Austria

Location

University Hospital Tuebingen, Diagnostic and Interventional Radiology

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

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

Hamburg, Hamburg, 20246, Germany

Location

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

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

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

Bad Krozingen, 79189, Germany

Location

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

Brandenburg, 14770, Germany

Location

Sana Kliniken Oberfranken Coburg

Coburg, 96450, Germany

Location

DIAKO gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie

Flensburg, 24939, Germany

Location

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

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie

Jena, 07747, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Bonifatius-Hospital Lingen (Ems)

Lingen, 49808, Germany

Location

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

Münster, 48149, Germany

Location

Elblandklinikum Radebeul, Gefäßzentrum

Radebeul, 01445, Germany

Location

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

Regensburg, 93049, Germany

Location

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

Rendsburg, 24768, Germany

Location

Kreiskrankenhaus Torgau

Torgau, 04860, Germany

Location

GRN Klinik Weinheim, Kardiologie/Angiologie

Weinheim, 69469, Germany

Location

Related Publications (1)

• 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.

  PMID: 35906491 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Ulf Teichgraeber, Prof. Dr.

  University Hospital Jena, Institute of Radiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Coordinating Investigator

Model Details: 1:1-randomization, parallel design, stratified by center.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: February 10, 2022
• Primary Completion: April 17, 2026
• Study Completion (Estimated): November 17, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DE (17)