Who is sponsoring NCT04475783?

NCT04475783 is sponsored by Jena University Hospital.

What drugs are being tested in NCT04475783?

Interventions in NCT04475783: Percutaneous Transluminal Angioplasty (PTA).

What condition does NCT04475783 study?

NCT04475783 studies Peripheral Artery Disease.

Is NCT04475783 still recruiting?

NCT04475783 is currently active, enrolled. Last updated 26 December 2025.

Last reviewed 2025-12-26 · How we verify

NCT04475783: SIRONA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled NA Last updated 26 December 2025

What this trial tests

NA trial testing Percutaneous Transluminal Angioplasty (PTA) in Peripheral Artery Disease in 478 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 April 2021

Primary endpoint
31 December 2023

31 December 2027

Quick facts

Lead sponsor	Jena University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	478
Start date	13 April 2021
Primary completion	31 December 2023
Estimated completion	31 December 2027
Sites	22 locations across Austria, Germany

Drugs / interventions tested

Percutaneous Transluminal Angioplasty (PTA)

Conditions studied

Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

Jena University Hospital

Who can join

18 and older, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial.
Teichgräber U, Ingwersen M, Platzer S, Lehmann T, et al · · 2021 · cited 19× · PMID 34583746 · DOI 10.1186/s13063-021-05631-9
Diversity in randomized clinical trials for peripheral artery disease: a systematic review.
Long C, Williams AO, McGovern AM, Jacobsen CM, et al · · 2024 · cited 5× · PMID 38350973 · DOI 10.1186/s12939-024-02104-8
Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease: The SIRONA Randomized Noninferiority Trial.
Teichgräber U, Ingwersen M, Lehmann T, Platzer S, et al · · 2026 · cited 2× · PMID 41706076 · DOI 10.1016/j.jacc.2025.12.017
Data sources and applied methods for paclitaxel safety signal discernment.
Gressler LE, Avila-Tang E, Mao J, Avalos-Pacheco A, et al · · 2023 · cited 1× · PMID 38463423 · DOI 10.3389/fcvm.2023.1331142

Verify or expand the search:

Other trials of Percutaneous Transluminal Angioplasty (PTA)

Trials testing the same drug.

NCT06071429 — Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease · NA · recruiting

Other recruiting trials for Peripheral Artery Disease

Currently open trials in the same condition.

NCT07374601 — The Value of Super-resolution Ultrasound Imaging for Peripheral Artery Disease · recruiting
NCT06686121 — Improving Mobility After Revascularization in Peripheral Artery Disease · Phase 3 · recruiting
NCT04433572 — Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee · Phase 3 · recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT07012070 — Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers · NA · recruiting

Other Jena University Hospital trials

Trials by the same sponsor.

NCT06355050 — Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer · not yet recruiting
NCT06749483 — The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units? · recruiting
NCT06765551 — AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness · recruiting
NCT06539377 — Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma · NA · not yet recruiting
NCT07428226 — Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04475783 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jena University Hospital
Last refreshed: 26 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04475783.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing