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

NCT04238546 | Active Not Recruiting DMC

• 1 other identifier: SirPAD Trial
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• The primary efficacy outcome is a composite of two major adverse limb events (MALE): unplanned major amputation of the target limb or endovascular/surgical target lesion re-vascularization for critical limb ischemia occurring within one year.

  * An unplanned major amputation is defined as any amputation above the ankle on the target limb, which was not planned or not expectable at the time of screening or randomization. Patients with scheduled amputation undergoing re-vascularization to improve wound healing are referred to as planned amputation and will not count for the primary outcome. * Critical limb ischemia is defined according to a Fontaine stage (classes III-IV) or according to criteria for a critical haemodynamic status, as defined in the ESC guidelines.

  One year

Secondary Outcomes (1)

• Composite of unplanned (major or minor) index-limb amputations or any target lesion re-vascularization within one year of enrollment

  One year

Other Outcomes (4)

• Death from all causes

  up to five years

• Serious adverse events (SAEs)

  one year

• Serious adverse device related events (SADE)

  up to one month

Study Arms (2)

Sirolimus-coated group

EXPERIMENTAL

Device: sirolimus-coated balloon catheter

Uncoated group

ACTIVE COMPARATOR

Device: uncoated balloon catheter

Interventions

sirolimus-coated balloon catheter DEVICE

angioplasty with sirolimus-coated balloon catheter

Sirolimus-coated group

uncoated balloon catheter DEVICE

angioplasty with uncoated balloon catheter

Uncoated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients requiring endovascular angioplasty for PAD located below the inguinal ligament
• Written informed consent obtained from participant or legal guardian prior to randomization; in patients requiring emergency interventional treatment who are temporarily not capable of providing informed consent, consent will be subsequently obtained after the procedure if strict conditions apply. These include the assessment of the presumed will and patient decree, and requires the allocation of an independent physician

You may not qualify if:

• Pregnancy, breastfeeding, or planned pregnancy within the trial period or women of childbearing potential not using an adequate method of contraception
• Patients with known intolerance or allergy to sirolimus
• Participation in this or other clinical trials during the previous 3 months

Sponsors & Collaborators

• Nils Kucher: lead

Study Sites (2)

University hospital zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

HFR Fribourg - Hôpital Cantonal / Kantonsspital

Fribourg, 1708, Switzerland

Location

Related Publications (2)

• Barco S, Engelberger RP, Held U, Fumagalli RM, Grigorean A, Hayoz D, Munger M, Sebastian T, Stadler R, Voci D, Wolf S, Baumann F, Tritschler T, von Stempel C, Periard D, Kucher N; SirPAD Investigators. Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease. N Engl J Med. 2026 Mar 30. doi: 10.1056/NEJMoa2600360. Online ahead of print.

  PMID: 41911022 DERIVED

• Barco S, Sebastian T, Voci D, Engelberger RP, Grigorean A, Holy E, Leeger C, Munger M, Periard D, Probst E, Spescha R, Held U, Kucher N. 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. Trials. 2022 Apr 21;23(1):334. doi: 10.1186/s13063-022-06242-8.

  PMID: 35449070 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Nils Kucher, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 23, 2020
• Study Start: November 3, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)