Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| D058729 | Peripheral Arterial Disease NIH | 0.50 |
| D007511 | Ischemia NIH | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004950 | Peripheral arterial stenosis HPO | 0.38 |
Navigate: Correlations HPO
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 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports