Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease

NCT ID: NCT04475783

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2027-12-31

Brief Summary

This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.

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

Detailed Description

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 fem-oropopliteal 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 study is based on the hypothesis that the usage of the Sirolimus-coated Magic Touch Sirolimus DCB is at least equal (non-inferior) with regards to efficacy and safety in comparison with a clinically well-established PTX coated balloon.

The objective of this prospective, randomized, multi-center, post-market study is to compare the Magic Touch Sirolimus DCB with Paclitaxel-coated DCB for treatment of high grade ste-notic or occluded lesions in SFA and / or P1 segment of the popliteal artery (PA) in PAD pa-tients.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Sirolimus; Paclitaxel; Drug-Coated Balloon; Percuteanous Transaluminal Angioplasty; PPA; SFA; MagicTouch PTA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sirolomus DCB group

Intervention with Sirolimus-coated balloon catheter

Group Type: EXPERIMENTAL

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type: COMBINATION_PRODUCT

PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery

Paclitaxel DCB group

Intervention with Paclitaxel-coated balloon catheter

Group Type: ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type: COMBINATION_PRODUCT

PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery

Interventions

Percutaneous Transluminal Angioplasty (PTA)

PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Subject age ≥ 18

2. Subject has been informed on the nature of the study, the duration of the study, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.

3. Rutherford category 2-4 according to the investigator's subjective evaluation

4. Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically

5. Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician

6. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 20 cm

7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation

8. Patency of P2 and P3 segment of the popliteal artery and at least one (1) infrapopliteal artery to the ankle (< 50 % diameter stenosis) in continuity with the femoropopliteal artery

9. Patency of ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis > 30 % may be treated during the index procedure to ensure sufficient inflow.

10. A guidewire has successfully traversed the target treatment segment intraluminal

11. Vascular disease in the opposite leg that requires treatment at the time point of index procedure is allowed, but has to be treated according to randomization or with POBA.

12. A patient can only be enrolled and randomized once with only one target lesion in the SIRONA trial. Please note that only the lesion in one limb can be treated as target lesion for index procedure.

Exclusion Criteria

1. Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing

2. Flow-limiting dissection after pre-dilatation

3. Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)

4. Presence of fresh thrombus in the target lesion

5. Presence of aneurysm in the target vessel/s

6. Prior vascular surgery (including atherectomy, bypass surgery) of the target limb

7. Prior stent in the target lesion

8. Stroke or heart attack within 3 months prior to enrollment

9. Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure

10. Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to index procedure

11. Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry devices

12. Enrolled in another investigational drug, device or biologic study

13. Life expectancy of less than one year in the investigator's opinion

14. 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

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

16. Receiving dialysis or immunosuppressant therapy

17. Pregnant or lactating females

18. History of major amputation in the same limb as the target lesion

• 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 University Hospital

UNKNOWN

Sponsor Role: collaborator

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ulf Teichgräber

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf Teichgraeber, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Jena, Institute of Radiology

Locations

Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie

Vienna, Vienna, Austria

Medizinische Universität Graz, Klinische Abteilung für Angiologie

Graz, , Austria

Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie

Klagenfurt, , Austria

Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie

Vienna, , Austria

Hanusch-Krankenhaus

Vienna, , Austria

University Heart Center Freiburg-Bad Krozingen

Bad Krozingen, , Germany

Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin

Bruchsal, , Germany

Sana Kliniken Oberfranken Coburg

Coburg, , Germany

Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie

Dresden, , Germany

Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie

Essen, , Germany

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

Flensburg, , Germany

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

Heidelberg, , Germany

Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt

Immenstadt im Allgäu, , Germany

University Hospital Jena

Jena, , Germany

Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie

Krefeld, , Germany

Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie

Leipzig, , Germany

Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie

Mainz, , Germany

St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie

Münster, , Germany

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

Münster, , Germany

Elblandklinikum Radebeul, Gefäßzentrum

Radebeul, , Germany

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

Rendsburg, , Germany

Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie

Torgau, , Germany

Countries

Austria; Germany

References

Teichgraber U, Ingwersen M, Platzer S, Lehmann T, Zeller T, Aschenbach R, Scheinert D. Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial. Trials. 2021 Sep 28;22(1):665. doi: 10.1186/s13063-021-05631-9.

Reference Type: BACKGROUND

PMID: 34583746 (View on PubMed)

Other Identifiers

DRKS00022452

Identifier Type: OTHER

Identifier Source: secondary_id

ZKSJ0127

Identifier Type: -

Identifier Source: org_study_id