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Corticosteroid

Temsirolimus + Dexamethasone for Peripheral Arterial Disease (TAP-DANCE Trial)

Phase 2
Recruiting
Research Sponsored by Mercator MedSystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has documented moderate to severe claudication (Rutherford 2-3) or Critical Limb Ischemia (CLI) with rest pain (Rutherford 4) in the target limb due to arterial stenosis within the superficial femoral and/or popliteal artery
Single or multiple de novo atherosclerotic or restenotic lesion(s) with ≥70% narrowing in the superficial femoral or popliteal artery meeting specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post intervention
Awards & highlights

TAP-DANCE Trial Summary

This trial will study the effects of temsirolimus on revascularized femoropopliteal lesions in patients with claudication or CLI. Patients will be followed for up to 60 months.

Who is the study for?
This trial is for adults aged 18-85 with moderate to severe claudication or critical limb ischemia due to arterial stenosis, who can walk and have a life expectancy over 2 years. Women of childbearing age must test negative for pregnancy and use birth control. Exclusions include recent heart attacks, strokes, sensitivity to study drugs, severe kidney issues, prior treatments in the target area, planned surgeries or amputations.Check my eligibility
What is being tested?
The study tests temsirolimus alone or combined with dexamethasone after revascularization surgery in patients with peripheral arterial disease. It aims to see if these drugs improve outcomes when delivered directly to the vessel's outer layer (adventitia). Participants will be monitored up to five years post-treatment.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to temsirolimus or dexamethasone, increased risk of infections due to immunosuppression from steroids, blood sugar level changes (especially important for diabetics), mood swings or weight gain from steroid use.

TAP-DANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe leg pain due to artery narrowing in my thigh or knee area.
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I have a blockage of 70% or more in my leg artery.
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I am between 18 and 85 years old.
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I can walk on my own.

TAP-DANCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness - Freedom from CD-TLR
Effectiveness - Primary patency
Safety - Freedom from MALE-POD at 30 days

TAP-DANCE Trial Design

2Treatment groups
Active Control
Group I: Group 1 - temsirolimus injectionActive Control1 Intervention
Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
Group II: Group 2 - temsirolimus and dexamethasone injectionActive Control1 Intervention
Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2

Find a Location

Who is running the clinical trial?

Mercator MedSystems, Inc.Lead Sponsor
9 Previous Clinical Trials
1,216 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
716 Patients Enrolled for Peripheral Arterial Disease

Media Library

Dexamethasone Sodium Phosphate (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03942601 — Phase 2
Peripheral Arterial Disease Research Study Groups: Group 1 - temsirolimus injection, Group 2 - temsirolimus and dexamethasone injection
Peripheral Arterial Disease Clinical Trial 2023: Dexamethasone Sodium Phosphate Highlights & Side Effects. Trial Name: NCT03942601 — Phase 2
Dexamethasone Sodium Phosphate (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03942601 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals accepted into this medical research?

"This trial has specified an age range for possible participants, which includes individuals 18 years and older but does not exceed 85."

Answered by AI

What medical condition is Group 2 - temsirolimus and dexamethasone injection commonly prescribed for?

"Ophthalmia, sympathetic ophthalmias, eye inflammation and branch retinal vein occlusions can all be effectively treated with a combination of temsirolimus and dexamethasone injections for Group 2 patients."

Answered by AI

May I qualify to take part in this trial?

"Hopefuls that wish to join this clinical trial must demonstrate peripheral arterial disease and be between 18-85 years of age. Approximately 60 individuals will take part in the study."

Answered by AI

Is this research endeavor still taking on participants?

"Affirmative. The clinical trial registry shows that this research is actively recruiting participants, with the initial posting being made on October 1st 2019 and amended most recently on August 31st 2020. Sixty volunteers are sought from nine different locations for involvement in the study."

Answered by AI

Is the combination of temsirolimus and dexamethasone injection sanctioned by the US Food & Drug Administration?

"Our team has assigned a rating of 2 to the combination of temsirolimus and dexamethasone injection, as this Phase 2 trial only provides limited evidence towards its safety but no data confirming efficacy."

Answered by AI

Is there an extensive presence of this research in the urban area?

"Nine different medical centres are taking part in the trial. These include Einstein Medical Center in Philadelphia, Baylor College of Medicine in Houston, and Arkansas Heart Hospital in Little Rock as well as 6 additional sites."

Answered by AI

To what extent is enrollment being sought out for this research?

"To meet the study's specifications, 60 eligible individuals must be enrolled. Potential participants can access this trial from medical centres such as Einstein Medical Center in Philadelphia and Baylor College of Medicine located in Houston."

Answered by AI

Are there records of other experiments conducted using Group 2 - temsirolimus and dexamethasone injection?

"Currently, Group 2 - temsirolimus and dexamethasone injection has 567 active studies. Of those clinical trials, 146 have reached Phase 3 of the trial process. While Mishawaka, Indiana is where most of these tests are conducted, there are 19221 locations across the country running trials for this medication."

Answered by AI

Who else is applying?

What site did they apply to?
Arkansas Heart Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
2019. "Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03942601.
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~11 spots leftby Apr 2025
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