NCT04433572 (TANGO-3) is a Phase 3 clinical trial of Temsirolimus in Peripheral Artery Disease, sponsored by Mercator MedSystems, Inc..

Who is sponsoring NCT04433572?

NCT04433572 is sponsored by Mercator MedSystems, Inc..

What drugs are being tested in NCT04433572?

Interventions in NCT04433572: Temsirolimus, Saline placebo.

What condition does NCT04433572 study?

NCT04433572 studies Peripheral Artery Disease, Critical Limb Ischemia.

Is NCT04433572 still recruiting?

NCT04433572 is currently recruiting now. Last updated 5 August 2025.

Last reviewed 2025-08-05 · How we verify

NCT04433572: TANGO-3

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

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

Recruiting now Phase 3 Last updated 5 August 2025

What this trial tests

Phase 3 trial testing Temsirolimus in Peripheral Artery Disease in 250 participants. Currently enrolling.

Timeline

30 July 2025

Primary endpoint
1 February 2028

1 August 2032

Quick facts

Lead sponsor	Mercator MedSystems, Inc.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	250
Start date	30 July 2025
Primary completion	1 February 2028
Estimated completion	1 August 2032
Sites	2 locations across United States

Drugs / interventions tested

Temsirolimus (temsirolimus) — full drug profile →
Saline placebo

Conditions studied

Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
Critical Limb Ischemia — all drugs for Critical Limb Ischemia →

Sponsor

Mercator MedSystems, Inc. — full company profile →

Who can join

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

Sponsor's own description

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

Publications & conference data

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

Role of lysosomes in physiological activities, diseases, and therapy.
Zhang Z, Yue P, Lu T, Wang Y, et al · · 2021 · cited 238× · PMID 33990205 · DOI 10.1186/s13045-021-01087-1
T Cells in Autoimmunity-Associated Cardiovascular Diseases.
Schwartz DM, Burma AM, Kitakule MM, Luo Y, et al · · 2020 · cited 38× · PMID 33117403 · DOI 10.3389/fimmu.2020.588776

Verify or expand the search:

Other trials of Temsirolimus

Trials testing the same drug.

NCT04199026 — Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sa · NA · recruiting
NCT03203525 — Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurre · Phase 1 · active not recruiting
NCT03942601 — Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropop · Phase 2 · terminated
NCT03158389 — NCT Neuro Master Match - N²M² (NOA-20) · Phase 1, PHASE2 · completed
NCT03297606 — Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) · Phase 2 · 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
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
NCT06657976 — Response to Exercise and Nitric Oxide in PAD · Phase 2 · recruiting

Other Mercator MedSystems, Inc. trials

Trials by the same sponsor.

NCT04858776 — Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacut · Phase 2 · recruiting
NCT04862468 — Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute F · Phase 2 · recruiting
NCT03942601 — Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropop · Phase 2 · terminated

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 NCT04433572 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Mercator MedSystems, Inc.
Last refreshed: 5 August 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/NCT04433572.

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