Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMercator MedSystems, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Participant is male or female, aged 18 years or older.
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.
Participant has severe claudication (Rutherford 3) or chronic limb-threatening ischemia (CLTI) (Rutherford 4-5) in the Target Limb.
Disqualifiers
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.
Participant is pregnant, nursing, or planning to become pregnant during the first 12 months after their enrollment in the study.
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.
Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
Trial design
Treatments tested in this trial
- Temsirolimus
- Saline placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov