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

Phase 3

Not yet recruiting

• Conditions: Peripheral Artery Disease; Critical Limb Ischemia
• Interventions: Drug: Saline placebo; Drug: Temsirolimus

• Registration Number: NCT04433572
• Lead Sponsor: Mercator MedSystems, Inc.

Brief 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.

Detailed Description

After completion of revascularization therapy and any decision to place stents, participants will be qualified for final enrollment in the study and will be randomized 2:1 and treated with the investigational drug or placebo, respectively. Any stents will be placed only after randomization, assignment, and adventitial drug therapy, although any stenting decisions (other than for treatment of AEs) must be made prior to randomization and adventitial drug delivery in order to avoid bias toward or against stenting.

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Study Start: 2025-04-30
• Primary Completion: 2028-02-01
• Study Completion: 2032-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline placebo	Saline placebo delivered to adventitia and perivascular tissue after primary revascularization
Temsirolimus	Temsirolimus	Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization

Primary Outcome Measures

Name	Time	Method
MALE + POD	30 Days	Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)
Freedom from Cinical Relevant Target Lesion Failure	6 Months	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

Secondary Outcome Measures

Name	Time	Method
Rate of clinically relevant restenosis (CRR)	12 months	Superiority of treatment vs. control group in the rate of clinically relevant restenosis (CRR)
Freedom from target lesion failure (TLF)	6 Months	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
Freedom from clinically relevant target lesion failure (CR-TLF)	12 Months	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