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

NCT ID: NCT04772300

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2028-11-17

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.

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sirolimus DCB group

Intervention with Sirolimus-coated balloon catheter

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

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

POBA group

Intervention with non-coated balloon catheter (POBA)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: COMBINATION_PRODUCT

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years at the time of consent.

2. 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.

3. 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).

4. Life expectancy > 1 year in the investigator's opinion.

5. Subject presenting with documented chronic limb-threatening ischemia (CLTI) in the target limb defined as Rutherford category 4, 5 or 6.

6. In case of Rutherford category 5 or 6: Subjects with 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) 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.

Exclusion Criteria

1. Subjects with major amputation of the target leg above the ankle joint.

2. 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.

3. Recent MI or stroke < 30 days prior to the index procedure.

4. Any vascular treatment with any drug-coated devices 4 weeks prior to index procedure

5. 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)

6. 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.

7. 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

8. Subjects with systemic vasculitis, such as Lupus Erythematosus or polymyalgia rheumatica on active treatment.

9. 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.

10. 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.

11. The subject is currently enrolled in another investigational device, drug or biological trial.

12. Female subjects who are breast feeding at the time of enrollment

13. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy

14. 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).

15. Previous procedure with drug-coated balloons in the target vessel within 6 months prior to index procedure.

16. 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.

17. Untreated significant (≥ 50 % residual stenosis measured by Duplex Sonography) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries.

18. 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.

19. Aneurysm in the target vessel.

20. Angiographic evidence of thrombus within target vessel.

21. Pre-dilatation resulted in a major (≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 50 %.

22. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concept Medical Inc.

INDUSTRY

Sponsor Role: collaborator

Vascuscience

UNKNOWN

Sponsor Role: collaborator

CoreLab Black Forest

UNKNOWN

Sponsor Role: collaborator

Center for Clinical Studies Jena

UNKNOWN

Sponsor Role: collaborator

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ulf Teichgräber

Principal Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf Teichgraeber, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Jena, Institute of Radiology

Locations

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

Vienna, , Austria

Hanusch-Krankenhaus

Vienna, , Austria

University Hospital Tuebingen, Diagnostic and Interventional Radiology

Tübingen, Baden-Wurttemberg, Germany

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

Hamburg, Hamburg, Germany

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

Bad Oeynhausen, North Rhine-Westphalia, Germany

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

Bad Krozingen, , Germany

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

Brandenburg, , Germany

Sana Kliniken Oberfranken Coburg

Coburg, , Germany

DIAKO gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie

Flensburg, , Germany

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

Heidelberg, , Germany

Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie

Jena, , Germany

University Hospital Leipzig

Leipzig, , Germany

Bonifatius-Hospital Lingen (Ems)

Lingen, , Germany

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

Münster, , Germany

Elblandklinikum Radebeul, Gefäßzentrum

Radebeul, , Germany

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

Regensburg, , Germany

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

Rendsburg, , Germany

Kreiskrankenhaus Torgau

Torgau, , Germany

GRN Klinik Weinheim, Kardiologie/Angiologie

Weinheim, , Germany

Countries

Austria; Germany

References

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.

Reference Type: BACKGROUND

PMID: 35906491 (View on PubMed)

Other Identifiers

ZKSJ0132

Identifier Type: -

Identifier Source: org_study_id