Who is sponsoring NCT04772300?

NCT04772300 is sponsored by Jena University Hospital.

What drugs are being tested in NCT04772300?

Interventions in NCT04772300: Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter, Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA).

What condition does NCT04772300 study?

NCT04772300 studies Peripheral Artery Disease.

Is NCT04772300 still recruiting?

NCT04772300 is currently active, enrolled. Last updated 26 December 2025.

Last reviewed 2025-12-26 · How we verify

NCT04772300: LIMES

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

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

Active, enrolled NA Last updated 26 December 2025

What this trial tests

NA trial testing Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter in Peripheral Artery Disease in 230 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 February 2022

Primary endpoint
17 April 2026

17 November 2028

Quick facts

Lead sponsor	Jena University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	230
Start date	10 February 2022
Primary completion	17 April 2026
Estimated completion	17 November 2028
Sites	19 locations across Austria, Germany

Drugs / interventions tested

Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter
Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)

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, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.

Publications & conference data

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

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
Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study.
Teichgräber U, Platzer S, Lehmann T, Ingwersen M, et al · · 2022 · cited 5× · PMID 35906491 · DOI 10.1007/s00270-022-03213-z

Verify or expand the search:

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 NCT04772300 (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/NCT04772300.

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