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TemsirolimusWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2182 Saline placebo Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D058729 Peripheral Arterial Disease NIH 0.58
D007511 Ischemia NIH 0.50

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0004950 Peripheral arterial stenosis HPO 0.45

There is one clinical trial.

Clinical Trials


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

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.

NCT04433572 Peripheral Artery Disease Critical Limb Ischemia Drug: Temsirolimus Drug: Saline placebo
MeSH:Peripheral Arterial Disease Ischemia
HPO:Peripheral arterial stenosis

Primary Outcomes

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 Months

Description: 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 Days

Secondary Outcomes

Description: 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 Months

Description: Death at the following time points

Measure: To determine non-inferiority in long-term mortality rate

Time: 12, 24, 36, 48, 60 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: MALE of the target limb

Measure: Freedom from major adverse limb events

Time: 30 days, 6, 12, 24 months

Description: 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 months

Description: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)

Measure: Reduction in unplanned minor amputations

Time: 30 days, 6, 12 months

Description: Rutherford category and change from baseline

Measure: Rutherford score improvement

Time: 30 days, 6, 12, 24 months

Description: WIfI category and change from baseline

Measure: WIfI score improvement

Time: 30 days, 6, 12, 24 months

Description: 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 months

Description: VascuQoL results and change from baseline

Measure: Patient reported quality of life benefits (VascuQoL)

Time: 30 days, 6, 12, 24 months

Description: WIQ results and change from baseline

Measure: Patient reported outcomes (walking impairment questionnaire) benefits

Time: 30 days, 6, 12, 24 months

Description: Primary patency rate Primary assisted patency rate

Measure: Primary and primary assisted patency rates

Time: 30 days, 6, 12, 24 months

Description: 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


Related HPO nodes (Using clinical trials)