Peripheral Artery DiseaseSIRONANCT04475783
Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease
A study testing Percutaneous Transluminal Angioplasty (PTA) in people with Peripheral Artery Disease, run by Jena University Hospital at 22 sites in 2 countries.
Trial 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. 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 13 Apr 2021to 31 Dec 2027
- 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
- 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
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- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
- Receiving dialysis or immunosuppressant therapy
- Pregnant or lactating females
- History of major amputation in the same limb as the target lesion
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Germany17 sites
University Heart Center Freiburg-Bad Krozingen
Bad Krozingen, 79189
Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin
Bruchsal, 76646
Sana Kliniken Oberfranken Coburg
Coburg, 96450
Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie
Dresden, 01307
Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie
Essen, 45147
DIAKO Krankenhaus gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Flensburg, 24939
Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie
Heidelberg, 69120
Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt
Immenstadt im Allgäu, 87509
University Hospital Jena
Jena, 07747
Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie
Krefeld, 47805
Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie
Leipzig, 04103
Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie
Mainz, 55131
St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie
Münster, 48145
Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie
Münster, 48149
Elblandklinikum Radebeul, Gefäßzentrum
Radebeul, 01445
Schön Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie
Rendsburg, 24768
Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie
Torgau, 04860
Austria5 sites
Medizinische Universität Graz, Klinische Abteilung für Angiologie
Graz, 8010
Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie
Klagenfurt, 9020
Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie
Vienna, State of Vienna, A-1090
Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
Vienna, 1090
Hanusch-Krankenhaus
Vienna, 1140
About this study
Official title: Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery
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.
Read the 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
- Being tested
- Percutaneous Transluminal Angioplasty (PTA)
- Keywords
- Peripheral Artery Disease, Sirolimus, Paclitaxel, Drug-Coated Balloon, Percuteanous Transaluminal Angioplasty, PPA, SFA, MagicTouch PTA
- 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)Combination product
PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery
| Study group | Role | What they receive |
|---|---|---|
| Sirolomus DCB group | Experimental | Intervention with Sirolimus-coated balloon catheter Receives: Combination Product: Percutaneous Transluminal Angioplasty (PTA) |
| Paclitaxel DCB group | Active comparator | Intervention with Paclitaxel-coated balloon catheter Receives: Combination Product: Percutaneous Transluminal Angioplasty (PTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through 12 months post-procedure
Secondary outcomes (10)
TLR rate
ocurrence of Target lesion revascularization (TLR) at certain time Points
Measured: 1, 6, 12, 24, 36, 48 and 60 months after study procedure
Rutherford classification
Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients
Measured: at 12 months after study procedure
Walking capacity assessment 1
patient-self-assessment of walking distance
Measured: at 1, 6, 12, 24, 36, 48 and 60 months after study procedure
Walking capacity assessment 2
6-minute Walking test (6MWT)
Measured: at 6, 12, 24, 48 months after study procedure
Walking capacity assessment 3
Treadmill test (optional)
Measured: at 6, 12, 24, 48 months after study procedure
Walking capacity assessment 4
Walking Impairment Questionnaire (WIQ); 20 questions (scale 0 to 4); best score 0, worst score 80
Measured: at 6, 12, 24, 48 months after study procedure
Duplex Ultrasound
Duplex-defined binary restenosis (PSVR >2.4) of the target lesion
Measured: post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention
ABI
Ankle brachial index (ABI)
Measured: at discharge, 6, 12, 24 and 48 months
Qualilty of Life Assessment
Quality of life assessment (QoL) by EQ5D-3L questionnaire; 5 questions (scale 1 to 5), best score 5, worst score 25
Measured: at 1 month, 6, 12, 24, 36, 48 and 60 months
Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization
Composite of freedom from all cause death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Measured: trough 60 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.
- First posted17 Jul 2020
- Study start13 Apr 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Concept Medical Inc., Vascuscience, CoreLab Black Forest
- Responsible party
- Principal investigator, Ulf Teichgräber, Jena University Hospital
- Investigators
- Ulf Teichgraeber, Prof. Dr., Study director, University Hospital Jena, Institute of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475783
- Sponsor's protocol ID
- ZKSJ0127
- Other IDs
- DRKS00022452
- Acronym
- SIRONA
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2020
- 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, 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.
PubMed 34583746Teichgraber U, Ingwersen M, Lehmann T, Platzer S, Kunstmann I, Steiner S, Schmidt A, Wittig T, Zeller T, Thieme M, Krankenberg H, Werner M, Brodmann M, Malyar N, Muller-Hulsbeck S, de Paoli L, Schlager O, Austermann M, Tepe G, Erbel C, Ito W, Wassmer R, Maiwald L, Aschenbach R, Wissgott C, Andrassy M, Wolf F, Beschorner U, Pech M, Katsanos K, Scheinert D. Subgroup variations in effectiveness of femoropopliteal sirolimus versus paclitaxel-coated balloon angioplasty: post hoc results of the randomised SIRONA trial. CVIR Endovasc. 2026 Aug 11;9(1):96. doi: 10.1186/s42155-026-00743-2.
PubMed 42576093
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery
- ClinicalTrials.gov ID
- NCT04475783
- Acronym / sponsor ID
- SIRONA / ZKSJ0127
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Sirolimus, Paclitaxel, Drug-Coated Balloon, Percuteanous Transaluminal Angioplasty, PPA, SFA, MagicTouch PTA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Concept Medical Inc., Vascuscience, CoreLab Black Forest
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1-randomization, parallel design, stratified by Center.
| Arm | Type | Receives |
|---|---|---|
| Sirolomus DCB group | Experimental | Combination Product: Percutaneous Transluminal Angioplasty (PTA)Intervention with Sirolimus-coated balloon catheter |
| Paclitaxel DCB group | Active comparator | Combination Product: Percutaneous Transluminal Angioplasty (PTA)Intervention with Paclitaxel-coated balloon catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Transluminal Angioplasty (PTA)PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery | Combination product | Paclitaxel DCB group, Sirolomus DCB group |
Primary outcome
Patency rate (Absence of clinically driven target lesion revascularization)
Time frame: one year after study procedure (PTA with medical product under investigation or comparator)
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
Safety outcome
Time frame: through 12 months post-procedure
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
10 secondary outcomes
TLR rate
Time frame: 1, 6, 12, 24, 36, 48 and 60 months after study procedure
Rutherford classification
Time frame: at 12 months after study procedure
Walking capacity assessment 1
Time frame: at 1, 6, 12, 24, 36, 48 and 60 months after study procedure
Walking capacity assessment 2
Time frame: at 6, 12, 24, 48 months after study procedure
Walking capacity assessment 3
Time frame: at 6, 12, 24, 48 months after study procedure
Walking capacity assessment 4
Time frame: at 6, 12, 24, 48 months after study procedure
Duplex Ultrasound
Time frame: post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention
ABI
Time frame: at discharge, 6, 12, 24 and 48 months
Qualilty of Life Assessment
Time frame: at 1 month, 6, 12, 24, 36, 48 and 60 months
Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization
Time frame: trough 60 months after study procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 34583746Teichgraber 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.
- Derived from this study: PubMed 42576093Teichgraber U, Ingwersen M, Lehmann T, Platzer S, Kunstmann I, Steiner S, Schmidt A, Wittig T, Zeller T, Thieme M, Krankenberg H, Werner M, Brodmann M, Malyar N, Muller-Hulsbeck S, de Paoli L, Schlager O, Austermann M, Tepe G, Erbel C, Ito W, Wassmer R, Maiwald L, Aschenbach R, Wissgott C, Andrassy M, Wolf F, Beschorner U, Pech M, Katsanos K, Scheinert D. Subgroup variations in effectiveness of femoropopliteal sirolimus versus paclitaxel-coated balloon angioplasty: post hoc results of the randomised SIRONA trial. CVIR Endovasc. 2026 Aug 11;9(1):96. doi: 10.1186/s42155-026-00743-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Teichgraeber, Prof. Dr. study director
University Hospital Jena, Institute of Radiology
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Transluminal Angioplasty (PTA) in people with Peripheral Artery Disease, run by Jena University Hospital at 22 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 12 inclusion and 18 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 22 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?
Patency rate (Absence of clinically driven target lesion revascularization) (time frame: one year after study procedure (PTA with medical product under investigation or comparator)). The study lists 2 primary outcomes in all. 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 NCT04475783, which also lists 2 linked publications.
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.