Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
Public ClinicalTrials.gov record NCT03942601. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03942601
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2019 (Actual)
- Primary completion
- Apr 30, 2021 (Actual)
- Completion
- Apr 30, 2021 (Actual)
- Last update posted
- Jul 10, 2024
2019 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| St. Joseph Hospital of Orange Heart and Vascular Center | Orange | California | 92868 | — |
| San Francisco VA Medical Center | San Francisco | California | 94121 | — |
| University of Colorado | Denver | Colorado | 80045 | — |
| Rocky Mountain Veterans Administration Hospital | Denver | Colorado | 80220 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | — |
| North Carolina Heart and Vascular | Raleigh | North Carolina | 27607 | — |
| University Hospital | Cleveland | Ohio | 44106 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03942601, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03942601 live on ClinicalTrials.gov.