Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Critical Limb Ischemia
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Block randomization will be stratified for Rutherford 3 and for Rutherford 4/5 participants such that each strata will be randomized 1:1. Block randomization will also be stratified by site such that each site will be assigned a 1:1 randomization.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The active vials and placebo vials will be identical in size, color and appearance on reconstitution. Investigators and participants will be blinded to assignment. 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. Participants will not be told of their treatment assignment until after they complete the trial.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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 1:1 and treated with the investigational drug or placebo. Any stents will be placed only after randomization, assignment, and advent...
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 1:1 and treated with the investigational drug or placebo. 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.
Tracking Information
- NCT #
- NCT04433572
- Collaborators
- Not Provided
- Investigators
- Not Provided
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