Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Mercator MedSystems, Inc.
You may qualify if…
- ✓ Pre-procedural:
- ✓ 1. Participant has signed and dated informed consent, is capable of understanding the nature, significance and implications of the clinical trial, and is willing to comply with all study procedures and follow-up visits for the duration of the study.
- ✓ 2. Participant is male or female, aged 18 years or older.
- ✓ 3. If participant is female and of reproductive potential: agreement to use a highly effective contraception (abstinence is acceptable) for at least 90 days after study treatment.
- ✓ 4. Participant has severe claudication (Rutherford 3) or chronic limb-threatening ischemia (CLTI) (Rutherford 4-5) in the Target Limb.
- ✓ Angiographic/Procedural:
- ✓ 5. Participant has up to two de novo or restenotic Qualified Target Lesions meeting the following criteria, each based on the Investigator's visual assessment. Target Lesions should be considered separate if they are located in separate vessels (not in the same blood path) or have more than 10 cm intervening normal artery.
- ✓ Diameter
You may not qualify if…
- ✕ Pre-procedural:
- ✕ 1. Participant is already enrolled in another clinical study of systemic or local vascular drug therapy or a vascular device study that has not completed its primary endpoint, including prior enrollment in this study.
- ✕ 2. Participant is pregnant, nursing, or planning to become pregnant during the first 12 months after their enrollment in the study.
- ✕ 3. Participant has presence of another anatomic or comorbid condition, or other medical, social, or psychological condition that, in the investigator's opinion, could limit the participant's ability to complete the clinical investigation or comply with follow-up requirements.
- ✕ 4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- ✕ 5. Participant has a life expectancy of ≤1 year.
- ✕ 6. Participant received in the prior 2 months, is currently receiving, or is planned to receive systemic immunosuppressive therapy, immunotherapy or chemotherapy.
- ✕ 7. Participant has platelet count \< 100,000 cells per microliter or \> 700,000 cells per microliter, or hemoglobin \< 7.5 g/dL.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04433572 · last updated 2025-08-05