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NCT03942601 · ClinicalTrials.gov registry record · Phase 2
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
A Phase 2 study, sponsored by Mercator MedSystems.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03942601: Clinical Trial Phase 2 study, sponsored by Mercator MedSystems.
NCT03942601 is a Phase 2 study that was terminated before completion, run by Mercator MedSystems. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03942601, a Phase 2 study, was terminated before completion, sponsored by Mercator MedSystems.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudication (Rutherford 2-3) or critical limb ischemia (CLI) with rest pain (Rutherford 4). Subjects will be followed for up to 60 months post index procedure.
Primary Outcome
Freedom from MALE-POD at 30 days
Interventions
- DRUG Temsirolimus
- DRUG Temsirolimus and dexamethasone sodium phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2021-04-30 |
| Phase | Phase 2 |
Why NCT03942601 stopped before completion
NCT03942601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Temsirolimus is the first listed.
NCT03942601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03942601 about?
NCT03942601 is a clinical study titled "Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization". This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudica...
What is the current status of trial NCT03942601?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-10-01. Estimated completion is 2021-04-30.
What interventions are being tested in trial NCT03942601?
The interventions under investigation include: Temsirolimus (DRUG), Temsirolimus and dexamethasone sodium phosphate (DRUG).
Who is sponsoring clinical trial NCT03942601?
This trial is sponsored by Mercator MedSystems, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03942601's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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