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

NCT04475783 | Active Not Recruiting DMC

• 2 other identifiers: ZKSJ0127DRKS00022452
• Study Type: interventional
• Target: 478
• Locations: 2 countries
• Sites: 22

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.

Conditions

Peripheral Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Patency rate (Absence of clinically driven target lesion revascularization)

  patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure or restenosis with PVR \> 2.4 evaluated by duplex ultrasound

  one year after study procedure (PTA with medical product under investigation or comparator)

• Safety outcome

  Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion

  through 12 months post-procedure

Secondary Outcomes (10)

• TLR rate

  1, 6, 12, 24, 36, 48 and 60 months after study procedure

• Rutherford classification

  at 12 months after study procedure

• Walking capacity assessment 1

  at 1, 6, 12, 24, 36, 48 and 60 months after study procedure

• Walking capacity assessment 2

  at 6, 12, 24, 48 months after study procedure

• Walking capacity assessment 3

  at 6, 12, 24, 48 months after study procedure

Study Arms (2)

Sirolomus DCB group

EXPERIMENTAL

Intervention with Sirolimus-coated balloon catheter

Combination Product: Percutaneous Transluminal Angioplasty (PTA)

Paclitaxel DCB group

ACTIVE COMPARATOR

Intervention with Paclitaxel-coated balloon catheter

Combination Product: Percutaneous Transluminal Angioplasty (PTA)

Interventions

Percutaneous Transluminal Angioplasty (PTA) COMBINATION_PRODUCT

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

Paclitaxel DCB group; Sirolomus DCB group

Eligibility Criteria

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

You may qualify if:

• Subject age ≥ 18
• 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.
• Rutherford category 2-4 according to the investigator's subjective evaluation
• Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically
• Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician
• 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
• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
• 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
• Patency of ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis \> 30 % may be treated during the index procedure to ensure sufficient inflow.
• A guidewire has successfully traversed the target treatment segment intraluminal
• 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.
• 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.

You may not qualify if:

• Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing
• Flow-limiting dissection after pre-dilatation
• Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)
• Presence of fresh thrombus in the target lesion
• Presence of aneurysm in the target vessel/s
• Prior vascular surgery (including atherectomy, bypass surgery) of the target limb
• Prior stent in the target lesion
• Stroke or heart attack within 3 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 index procedure
• Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry devices
• Enrolled in another investigational drug, device or biologic study
• 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

Sponsors & Collaborators

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

Study Sites (22)

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

Vienna, Vienna, A-1090, Austria

Location

Medizinische Universität Graz, Klinische Abteilung für Angiologie

Graz, 8010, Austria

Location

Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie

Klagenfurt, 9020, Austria

Location

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

Vienna, 1090, Austria

Location

Hanusch-Krankenhaus

Vienna, 1140, Austria

Location

University Heart Center Freiburg-Bad Krozingen

Bad Krozingen, 79189, Germany

Location

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

Bruchsal, 76646, Germany

Location

Sana Kliniken Oberfranken Coburg

Coburg, 96450, Germany

Location

Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie

Dresden, 01307, Germany

Location

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

Essen, 45147, Germany

Location

DIAKO Krankenhaus 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

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

Immenstadt im Allgäu, 87509, Germany

Location

University Hospital Jena

Jena, 07747, Germany

Location

Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie

Krefeld, 47805, Germany

Location

Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie

Leipzig, 04103, Germany

Location

Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie

Mainz, 55131, Germany

Location

St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie

Münster, 48145, Germany

Location

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

Münster, 48149, Germany

Location

Elblandklinikum Radebeul, Gefäßzentrum

Radebeul, 01445, Germany

Location

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

Rendsburg, 24768, Germany

Location

Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie

Torgau, 04860, Germany

Location

Related Publications (1)

• 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.

  PMID: 34583746 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

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

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: April 13, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (17); AU (5)