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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Temsirolimus
Drug0.1 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
DrugSaline 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: TemsirolimusActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from Cinical Relevant Target Lesion Failure
Superiority of treatment vs. control group in the composite freedom from the following: * Clinically Relevant Target Lesion Occlusion * Clinically Driven Target Lesion Revascularization * Ischemia-Driven Major Amputation of the Target Limb
Time frame
6 Months2
MALE + POD
Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)
Time frame
30 DaysSecondary outcomes
1
Rate of clinically relevant restenosis (CRR)
Superiority of treatment vs. control group in the rate of clinically relevant restenosis (CRR)
Time frame
6 months2
Freedom from target lesion failure (TLF)
Superiority of treatment vs. control group in the composite freedom from the following: * Target Lesion Occlusion * Clinically Driven Target Lesion Revascularization * Ischemia-Driven Major Amputation of the target limb
Time frame
6 Months3
Freedom from clinically relevant target lesion failure (CR-TLF)
Superiority of treatment vs. control group in the composite freedom from the following: * Clinically Relevant Target Lesion Occlusion * Clinically Driven Target Lesion Revascularization * Ischemia-Driven Major Amputation of the target limb
Time frame
12 Months4
Rate of clinically relevant restenosis (CRR)
Superiority of treatment vs. control group in the rate of clinically relevant restenosis (CRR)
Time frame
12 monthsOther outcomes
1
Safety and tolerability will be assessed from overall rate of adverse events (subclassified as major, serious, non-serious, unanticipated, revascularization procedure-related, device-related and drug-related).
AEs/ARs will be categorized into one of the following: * MALE of the target limb * Non-MALE target limb SAE/SAR * Other SAE/SAR * Non-serious AE/AR AEs/ARs will further be classified as: * Expected * UADE * SUSAR AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following: * Revascularization procedure * Use of the Bullfrog device * The study drug
Time frame
1, 6, 12, 24 months2
Freedom from target lesion failure metrics
Individual endpoints measuring each of the following: * Freedom from clinically relevant target lesion failure (CR-TLF) * Freedom from target lesion failure (TLF) * Freedom from clinically relevant target lesion occlusion (CR-TLO) * Freedom from any target lesion occlusion (TLO) * Freedom from clinically relevant restenosis (CRR) of the target lesion
Time frame
1, 6, 12 and 24 months3
Freedom from MALE of the index limb and all-cause death
In composite and separately, the following will be measured: * MALE of the index limb * All-cause death
Time frame
1, 6, 12, 24 months4
Long-term freedom from all-cause death
Rate of freedom from all-cause death
Time frame
36, 48, 60 monthsSponsors and contacts
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Source ClinicalTrials.gov