NCT04238546

Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty

Active, enrolled NA Last updated 19 February 2026

What this trial tests

NA trial testing sirolimus-coated balloon catheter in Peripheral Arterial Disease in 1,200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 November 2020

Primary endpoint
31 December 2025

31 December 2029

Quick facts

Lead sponsor	Nils Kucher
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,200
Start date	3 November 2020
Primary completion	31 December 2025
Estimated completion	31 December 2029
Sites	2 locations across Switzerland

Drugs / interventions tested

• sirolimus-coated balloon catheter
• uncoated balloon catheter

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Nils Kucher

Who can join

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

Sponsor's own description

The SirPAD trial is an academic, investigator-initiated, single-center, randomized, non-inferiority, open-label clinical trial investigating whether the use of sirolimus-coated balloon catheters in patients with peripheral artery disease of the femoro-popliteal or below-the-knee segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb re-vascularization) and may provide advantages concerning important secondary outcomes, which will be evaluated using a pre-specified hierarchical order as part of the primary analysis.

Publications & conference data

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

1. 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
2. Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the "SirPAD" randomized controlled trial.
   Barco S, Sebastian T, Voci D, Engelberger RP, et al · · 2022 · cited 3× · PMID 35449070 · DOI 10.1186/s13063-022-06242-8
3. Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease.
   Barco S, Engelberger RP, Held U, Fumagalli RM, et al · · 2026 · cited 1× · PMID 41911022 · DOI 10.1056/nejmoa2600360
4. Sirolimus-coated balloons for peripheral arterial disease: walking free into the future of endovascular treatment.
   Fumagalli RM, Barco S. · · 2024 · cited 1× · PMID 39790195 · DOI 10.21037/cdt-24-484