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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03942601
The ClinicalTrials.gov registry entry for NCT03942601 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercator MedSystems, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temsirolimus is the first listed.
NCT03942601 reports 0 study locations.
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.
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