Name (Synonyms) | Correlation | |
---|---|---|
D058729 | Peripheral Arterial Disease NIH | 0.58 |
D007511 | Ischemia NIH | 0.50 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0004950 | Peripheral arterial stenosis HPO | 0.45 |
There is one clinical 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.
Description: 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
Measure: Freedom from Cinical Relevant Target Lesion Failure Time: 6 MonthsDescription: Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)
Measure: MALE + POD Time: 30 DaysDescription: 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
Measure: Freedom from Target Lesion Failure Time: 6 MonthsDescription: Death at the following time points
Measure: To determine non-inferiority in long-term mortality rate Time: 12, 24, 36, 48, 60 monthsDescription: Composite of all-cause death or MALE of the target limb
Measure: To determine non-inferiority in freedom from all-cause death or major adverse limb event. Time: 30 days, 6, 12 monthsDescription: Freedom from death and ischemia-driven major amputation of the target limb
Measure: To determine non-inferiority in amputation-free survival. Time: 30 days, 6, 12, 24 monthsDescription: 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
Measure: 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). Time: 30 days, 6, 12, 24 monthsDescription: Taken individually: Ischemia-driven major amputation of the target limb CD-TLR Clinically relevant target lesion occlusion Any target lesion occlusion
Measure: Change of the individual components of the primary and secondary endpoints (ischemia-driven major amputation, clinically driven target lesion revascularization, clinically relevant target lesion occlusion or all target lesion occlusion) Time: 6, 12, 24 monthsDescription: MALE of the target limb
Measure: Freedom from major adverse limb events Time: 30 days, 6, 12, 24 monthsDescription: Total size of foot wounds on the target limb, percent and absolute change from baseline Status of foot wounds on the target limb Unassisted wound healing
Measure: Composite of the following wound healing measures Time: 30 days, 6, 12 monthsDescription: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)
Measure: Reduction in unplanned minor amputations Time: 30 days, 6, 12 monthsDescription: Rutherford category and change from baseline
Measure: Rutherford score improvement Time: 30 days, 6, 12, 24 monthsDescription: WIfI category and change from baseline
Measure: WIfI score improvement Time: 30 days, 6, 12, 24 monthsDescription: Ankle-brachial index and change from baseline Toe-brachial index and change from baseline Toe pressure and change from baseline
Measure: Composite of hemodynamic improvement measures (ABI, TBI and toe pressure) Time: 30 days, 6, 12, 24 monthsDescription: VascuQoL results and change from baseline
Measure: Patient reported quality of life benefits (VascuQoL) Time: 30 days, 6, 12, 24 monthsDescription: WIQ results and change from baseline
Measure: Patient reported outcomes (walking impairment questionnaire) benefits Time: 30 days, 6, 12, 24 monthsDescription: Primary patency rate Primary assisted patency rate
Measure: Primary and primary assisted patency rates Time: 30 days, 6, 12, 24 monthsDescription: Primary sustained clinical improvement rate Secondary sustained clinical improvement rate
Measure: Primary and secondary sustained clinical improvement rates Time: 30 days, 6, 12, 24 months