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

Part of paid clinical trials in Houma, Louisiana.

Sponsor
Mercator MedSystems, Inc.
Study ID
NCT04433572
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temsirolimus — DRUG
    0.1 mg/mL temsirolimus, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.
  • Saline placebo — DRUG
    Saline placebo, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.

Study Details

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.

Key Dates

Start date
Jul 30, 2025
Status verified
Jul 2025
Primary completion
Feb 1, 2028
Completion
Aug 1, 2032

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Temsirolimus
    Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization
  • Placebo Comparator: Placebo
    Saline placebo delivered to adventitia and perivascular tissue after primary revascularization

Primary Outcome Measure

Freedom from Cinical Relevant Target Lesion Failure [ Time Frame: 6 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cardiovascular Institute of the SouthHoumaLouisiana70360-
UT SouthwesternDallasTexas75235-

Find similar trials in Houma, LA

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
Cardiovascular Institute of the South· Houma, LAUT Southwestern· Dallas, TX

Related Studies