Actively Recruiting
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Led by Mercator MedSystems, Inc. · Updated on 2025-08-05
250
Participants Needed
2
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has signed informed consent and agrees to follow study procedures and visits
- Participant is male or female, aged 18 years or older
- Female participants of reproductive potential agree to use highly effective contraception for at least 90 days after treatment
- Participant has severe claudication (Rutherford 3) or chronic limb-threatening ischemia (Rutherford 4-5) in the target limb
- Participant has up to two target lesions meeting specific size, location, and severity criteria confirmed by the investigator
- Participant has successful revascularization with residual stenosis less than 30% and good blood flow to the foot after treatment
You will not qualify if you...
- Participant is enrolled in another vascular drug or device study that has not completed its primary endpoint
- Participant is pregnant, nursing, or plans pregnancy within 12 months of enrollment
- Participant has medical, social, or psychological conditions limiting study compliance
- Mentally incapacitated individuals or those without legal authority
- Participant's life expectancy is 1 year or less
- Recent or planned systemic immunosuppressive therapy, immunotherapy, or chemotherapy
- Abnormal blood counts (platelets or hemoglobin below or above specified levels)
- Known allergies or contraindications to study drugs or contrast medium (except manageable contrast allergies)
- Central nervous system tumor
- Recent heart attack (within 30 days), stroke (within 90 days), or brain hemorrhage (within 1 year)
- Recent or planned vascular surgery within 30 days of the index procedure, with limited exceptions
- Patent bypass graft too close to target lesion
- Bedridden or unable to walk independently
- Planned major amputation in the target limb
- Recent major amputation or limited mobility
- Signs of advanced limb infection or septicemia
- Extensive tissue loss requiring complex foot reconstruction or non-traditional amputations
- Elevated bilirubin or severely reduced kidney function (except stable dialysis patients)
- Severe peripheral artery disease limiting successful treatment
- Untreated severe vessel issues or complications
- Recent or prior use of certain vascular therapies or devices in the target lesion
- Severe dissection or aneurysm near target lesion
- Presence of thrombus, embolism, or lesions that cannot be crossed with a guide wire
- Heavy calcification preventing device use
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
2
UT Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
K
Kirk Seward, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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