Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mercator MedSystems, Inc.
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria

• Age ≥18 years and <90 years

• Patient has documented severe claudication (Rutherford 3) or chronic Critical Limb Ischemia (CLI) (Rutherford 4-5) in the target limb due to arterial stenosis between the knee joint space and the ankle joint prior to the study procedure

• Life expectancy >1 year in the Investigator's opinion

• Patient has been informed of the nature of the study, agrees to participate, agrees to the follow-up schedule, and has signed an IRB approved consent form

• Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a highly effective method of birth control for one month preceding and 12 months following study treatment

Exclusion Criteria

• Patient is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study

• Patient is unwilling or unlikely to comply with visit schedule

• Patient is incapable of providing consent and/or incapable of understanding the nature, significance and implications of the clinical trial

• Patient is already receiving or planned to receive systemic immunotherapy or chemotherapy

• Patient is at high risk of thrombosis and taking systemic anticoagulant therapy that is unable to be withheld during the procedure

• Patient has a CNS tumor or elevated risk for intracerebral bleeding and is receiving chronic anticoagulation therapy e.g. warfarin or oral anticoagulant (note: chronic antiplatelet therapy, e.g. aspirin and clopidogrel, and procedural anticoagulation therapy, e.g. heparin or bivalirudin, are allowed)

• Recent (<30 days prior to study procedure) myocardial infarction

• Cerebrovascular accident <60 days prior to the study procedure or any history of intracerebral hemorrhage

• Any surgical or endovascular procedure performed within 14 days prior to the index procedure or planned within 30 days post index procedure is exclusionary; allowable exceptions to this exclusion include the following:

1. concurrent procedures during the index procedure

2. prior staged revascularization in the target limb, e.g. for inflow revascularization within 14 days of and prior to the index procedure

• Planned major (above the ankle) target limb amputation

• Active foot infection, including osteomyelitis of the metatarsal or more proximal region; allowable exceptions to this exclusion include the following:

1. osteomyelitis in the toes

2. mild cellulitis around the perimeter of gangrene

3. small ulcers (<25mm largest diameter)

• Inability to receive temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions

• Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are determined to be primarily neuropathic in nature or non-ischemic in origin

• Risk of amputation based on WIfI clinical staging = HIGH

• Patient has active viral infection of SARS-CoV-2 or active disease diagnosis of COVID-19 (must be determined within 7 days of index procedure)

• Patient has a bilirubin level of >1.5xULN

• Estimated glomerular filtration rate (eGFR, calculated from serum creatinine using an isotope dilution mass spectrometry (IDMS)-traceable equation) less than 30 mL/min, except for patients with end stage renal disease on chronic hemodialysis