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New balloon treatment for blocked leg arteries put to the test

NCT ID NCT04475783

Disease control Sponsor: Jena University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of drug-coated balloons used to open blocked arteries in the leg. About 478 people with peripheral artery disease will receive either a sirolimus-coated balloon or a paclitaxel-coated balloon. The goal is to see if the sirolimus balloon works as well as the standard paclitaxel balloon at keeping arteries open after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus-coated balloon catheter
What this could lead to
If successful, this could offer an alternative treatment for leg artery blockages that avoids the need for surgery.
What could go wrong
This is a non-inferiority trial, so it only aims to show sirolimus is not worse than paclitaxel, not that it is better. Results may not apply to all patients or lesions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 478 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral artery disease

Contacts and locations

Locations

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

    Flensburg, 24939, Germany

  • Elblandklinikum Radebeul, Gefäßzentrum

    Radebeul, 01445, Germany

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

    Bruchsal, 76646, Germany

  • Hanusch-Krankenhaus

    Vienna, 1140, Austria

  • Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie

    Krefeld, 47805, Germany

  • Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie

    Klagenfurt, 9020, Austria

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

    Immenstadt im Allgäu, 87509, Germany

  • Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie

    Torgau, 04860, Germany

  • Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie

    Mainz, 55131, Germany

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

    Vienna, State of Vienna, A-1090, Austria

  • Medizinische Universität Graz, Klinische Abteilung für Angiologie

    Graz, 8010, Austria

  • Sana Kliniken Oberfranken Coburg

    Coburg, 96450, Germany

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

    Rendsburg, 24768, Germany

  • St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie

    Münster, 48145, Germany

  • University Heart Center Freiburg-Bad Krozingen

    Bad Krozingen, 79189, Germany

  • University Hospital Jena

    Jena, 07747, Germany

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

    Vienna, 1090, Austria

  • Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie

    Dresden, 01307, Germany

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

    Essen, 45147, Germany

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

    Heidelberg, 69120, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie

    Leipzig, 04103, Germany

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

    Münster, 48149, Germany

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