RecruitingPhase 3

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

United States250 participantsStarted 2025-07-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.
✓. ≥70% diameter stenosis anywhere within the Target Lesion or ≥50% diameter stenosis spanning at least 10 cm of length.
✓. Reference (normal) vessel diameter ≥2 mm and ≤8 mm. Location
✓. Any lesion chosen as a Target Lesion is in or spans at least one below-knee popliteal (P3 segment), tibial, or peroneal artery and is a culprit for dominant disease symptoms based on Investigator's assessment.

What they're measuring

Freedom from Cinical Relevant Target Lesion Failure

Timeframe: 6 Months

MALE + POD

Timeframe: 30 Days

Trial details

NCT IDNCT04433572

SponsorMercator MedSystems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Kirk Seward, PhD

(510) 614-4555 kseward@mercatormed.com

View on ClinicalTrials.gov More Peripheral Artery Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.
✓. ≥70% diameter stenosis anywhere within the Target Lesion or ≥50% diameter stenosis spanning at least 10 cm of length.
✓. Reference (normal) vessel diameter ≥2 mm and ≤8 mm. Location
✓. Any lesion chosen as a Target Lesion is in or spans at least one below-knee popliteal (P3 segment), tibial, or peroneal artery and is a culprit for dominant disease symptoms based on Investigator's assessment.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria