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NCT04433572 · ClinicalTrials.gov registry record · Phase 3
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
A Phase 3 study of Peripheral Artery Disease and Critical Limb Ischemia, sponsored by Mercator MedSystems.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 2
- Study locations
NCT04433572: Recruiting Phase 3 study of Peripheral Artery Disease and Critical Limb Ischemia, sponsored by Mercator MedSystems.
NCT04433572 is a Phase 3 study of Peripheral Artery Disease and Critical Limb Ischemia that is actively recruiting participants, run by Mercator MedSystems. The registered enrollment target is 250 participants, above the 122-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (105% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04433572, a Phase 3 study of Peripheral Artery Disease and Critical Limb Ischemia, is actively recruiting participants, sponsored by Mercator MedSystems.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Superiority of treatment vs. control group in the composite freedom from the following: * Clinically Relevant Target Lesion Occlusion * Clinically Driven Target Lesion Revascularization * Ischemia-Driven Major Amputation of the Target Limb
Conditions Studied
Interventions
- DRUG Temsirolimus
- DRUG Saline placebo
Study Locations (2)
Louisiana
- Cardiovascular Institute of the South - Houma
Texas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-07-30 |
| Est. Completion | 2032-08-01 |
| Phase | Phase 3 |
What NCT04433572 shows while recruiting
NCT04433572 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 122-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (105% higher).
The record links to 2 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Temsirolimus is the first listed.
NCT04433572 reports a single indexed study location in Louisiana, Texas.
Frequently Asked Questions
What is clinical trial NCT04433572 about?
NCT04433572 is a clinical study titled "Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee". 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 rev...
What is the current status of trial NCT04433572?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2025-07-30. Estimated completion is 2032-08-01.
What conditions does trial NCT04433572 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, Critical Limb Ischemia.
What interventions are being tested in trial NCT04433572?
The interventions under investigation include: Temsirolimus (DRUG), Saline placebo (DRUG).
Who is sponsoring clinical trial NCT04433572?
This trial is sponsored by Mercator MedSystems, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04433572 being conducted?
This trial has 2 study locations across Louisiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04433572's enrollment target sits among peer trials
250 7th of 50 higher than 43 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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