Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Artery Disease (PAD) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Artery Disease (PAD). ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Peripheral Artery Disease (PAD): 3 are currently recruiting; 2 are active or not yet recruiting; 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04433572). The largest enrolment is 478 participants (NCT07359807). Registration activity spans 2020 to 2026. The literature layer holds 6 publications for this pair: 1 Cochrane review, 1 meta-analysis and 4 clinical trial publications. Publication years run from 2012 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Peripheral Arterial Disease ranks 292 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive disease; spontaneous improvement rare; limb ischaemia worsens in 25-30% over 5 years; major adverse limb events (MALE) in 10-15%/year in advanced PAD; major amputation in 5-10% at 5 years without revascularisation.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 57.5 (trials 20.5, literature 17.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 2 active / not yet recruiting, 1 completed, 2 other |
| Linked publications | 6 (4 clinical trial publications, 1 Cochrane review, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ABO |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04433572 | Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee 2025 | recruiting | Phase 3 | 250 |
| NCT05132361 | SELUTION4SFA Trial 2022 | active, not recruiting | Not applicable | 300 |
| NCT04107298 | Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon 2020 | completed | Not applicable | 35 |
| NCT07359807 | A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries. 2026 | not yet recruiting | PHASE2, PHASE3 | 478 |
| NCT04584632 | The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery 2020 | recruiting | Not applicable | 100 |
| NCT07144150 | EVERO Drug-coated Balloon (DCB) Randomized Trial 2026 | recruiting | Not applicable | 410 |
| NCT05450042 | Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation 2022 | status unknown | Not applicable | 70 |
| NCT05267548 | Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries 2022 | status unknown | Not applicable | 143 |
Published literature
- Clinical trial publication MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI TrialChoke ETC, Peh EYL, Tang TY et al. · Annals of vascular surgery · 2024 · PMID 38579912
- Cochrane review Different drugs in drug-eluting stents for peripheral artery disease: a systematic evaluation and Bayesian meta-analysisChen K, Xu L, Liu X · Journal of thrombosis and thrombolysis · 2024 · PMID 38281227
- Meta-analysis A systematic review and meta-analysis of sirolimus-eluting stents for treatment of below-the-knee arterial diseaseFong KY, Xin L, Ng J et al. · Journal of vascular surgery · 2023 · PMID 36183989
- Clinical trial publication Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary resultsTaneva GT, Pitoulias GA, Abu Bakr N et al. · The Journal of cardiovascular surgery · 2022 · PMID 35179337
- Clinical trial publication Wound Healing Outcomes and Health-Related Quality-of-Life Changes in the ACHILLES Trial: 1-Year Results From a Prospective Randomized Controlled Trial of Infrapopliteal Balloon Angioplasty Versus Sirolimus-Eluting Stenting in Patients With Ischemic Peripheral Arterial DiseaseKatsanos K, Spiliopoulos S, Diamantopoulos A et al. · JACC. Cardiovascular interventions · 2016 · PMID 26777329
- Clinical trial publication A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trialScheinert D, Katsanos K, Zeller T et al. · Journal of the American College of Cardiology · 2012 · PMID 23194941
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ABO. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Peripheral Artery Disease (PAD)?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Artery Disease (PAD) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Artery Disease (PAD). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Peripheral Artery Disease (PAD)?
ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Peripheral Artery Disease (PAD): 3 are currently recruiting; 2 are active or not yet recruiting; 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04433572). The largest enrolment is 478 participants (NCT07359807). Registration activity spans 2020 to 2026.
What does the evidence show for Sirolimus in Peripheral Artery Disease (PAD)?
Sirolimus has both completed registered trials and synthesis-level publications linked to Peripheral Artery Disease (PAD). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ABO. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.