- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433572
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee (TANGO-3)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kirk Seward, PhD
- Phone Number: (510) 614-4555
- Email: kseward@mercatormed.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Age ≥18 years and <90 years
- Patient has documented severe claudication (Rutherford 3) or chronic Critical Limb Ischemia (CLI) (Rutherford 4-5) in the target limb due to arterial stenosis between the knee joint space and the ankle joint prior to the study procedure
- Life expectancy >1 year in the Investigator's opinion
- Patient has been informed of the nature of the study, agrees to participate, agrees to the follow-up schedule, and has signed an IRB approved consent form
- Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a highly effective method of birth control for one month preceding and 12 months following study treatment
Exclusion Criteria
- Patient is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study
- Patient is unwilling or unlikely to comply with visit schedule
- Patient is incapable of providing consent and/or incapable of understanding the nature, significance and implications of the clinical trial
- Patient is already receiving or planned to receive systemic immunotherapy or chemotherapy
- Patient is at high risk of thrombosis and taking systemic anticoagulant therapy that is unable to be withheld during the procedure
- Patient has a CNS tumor or elevated risk for intracerebral bleeding and is receiving chronic anticoagulation therapy e.g. warfarin or oral anticoagulant (note: chronic antiplatelet therapy, e.g. aspirin and clopidogrel, and procedural anticoagulation therapy, e.g. heparin or bivalirudin, are allowed)
- Recent (<30 days prior to study procedure) myocardial infarction
- Cerebrovascular accident <60 days prior to the study procedure or any history of intracerebral hemorrhage
Any surgical or endovascular procedure performed within 14 days prior to the index procedure or planned within 30 days post index procedure is exclusionary; allowable exceptions to this exclusion include the following:
- concurrent procedures during the index procedure
- prior staged revascularization in the target limb, e.g. for inflow revascularization within 14 days of and prior to the index procedure
- Planned major (above the ankle) target limb amputation
Active foot infection, including osteomyelitis of the metatarsal or more proximal region; allowable exceptions to this exclusion include the following:
- osteomyelitis in the toes
- mild cellulitis around the perimeter of gangrene
- small ulcers (<25mm largest diameter)
- Inability to receive temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions
- Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are determined to be primarily neuropathic in nature or non-ischemic in origin
- Risk of amputation based on WIfI clinical staging = HIGH
- Patient has active viral infection of SARS-CoV-2 or active disease diagnosis of COVID-19 (must be determined within 7 days of index procedure)
- Patient has a bilirubin level of >1.5xULN
- Estimated glomerular filtration rate (eGFR, calculated from serum creatinine using an isotope dilution mass spectrometry (IDMS)-traceable equation) less than 30 mL/min, except for patients with end stage renal disease on chronic hemodialysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Temsirolimus
Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization
|
0.1 mg/mL temsirolimus, including contrast medium with approximately 75 mg iodine per mL.
The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment.
The same volumes of comparator agent will be delivered in control participants.
|
Placebo Comparator: Placebo
Saline placebo delivered to adventitia and perivascular tissue after primary revascularization
|
Saline placebo, including contrast medium with approximately 75 mg iodine per mL.
The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment.
The same volumes of comparator agent will be delivered in control participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from Cinical Relevant Target Lesion Failure
Time Frame: 6 Months
|
Superiority of treatment vs. control group in the composite freedom from the following:
|
6 Months
|
MALE + POD
Time Frame: 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)
|
30 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from Target Lesion Failure
Time Frame: 6 Months
|
Superiority of treatment vs. control group in the composite freedom from the following:
|
6 Months
|
To determine non-inferiority in long-term mortality rate
Time Frame: 12, 24, 36, 48, 60 months
|
Death at the following time points
|
12, 24, 36, 48, 60 months
|
To determine non-inferiority in freedom from all-cause death or major adverse limb event.
Time Frame: 30 days, 6, 12 months
|
Composite of all-cause death or MALE of the target limb
|
30 days, 6, 12 months
|
To determine non-inferiority in amputation-free survival.
Time Frame: 30 days, 6, 12, 24 months
|
Freedom from death and ischemia-driven major amputation of the target limb
|
30 days, 6, 12, 24 months
|
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 Frame: 30 days, 6, 12, 24 months
|
AEs/ARs will be categorized into one of the following:
AEs/ARs will further be classified as:
AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following:
|
30 days, 6, 12, 24 months
|
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 Frame: 6, 12, 24 months
|
Taken individually:
|
6, 12, 24 months
|
Freedom from major adverse limb events
Time Frame: 30 days, 6, 12, 24 months
|
MALE of the target limb
|
30 days, 6, 12, 24 months
|
Composite of the following wound healing measures
Time Frame: 30 days, 6, 12 months
|
|
30 days, 6, 12 months
|
Reduction in unplanned minor amputations
Time Frame: 30 days, 6, 12 months
|
Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)
|
30 days, 6, 12 months
|
Rutherford score improvement
Time Frame: 30 days, 6, 12, 24 months
|
Rutherford category and change from baseline
|
30 days, 6, 12, 24 months
|
WIfI score improvement
Time Frame: 30 days, 6, 12, 24 months
|
WIfI category and change from baseline
|
30 days, 6, 12, 24 months
|
Composite of hemodynamic improvement measures (ABI, TBI and toe pressure)
Time Frame: 30 days, 6, 12, 24 months
|
|
30 days, 6, 12, 24 months
|
Patient reported quality of life benefits (VascuQoL)
Time Frame: 30 days, 6, 12, 24 months
|
VascuQoL results and change from baseline
|
30 days, 6, 12, 24 months
|
Patient reported outcomes (walking impairment questionnaire) benefits
Time Frame: 30 days, 6, 12, 24 months
|
WIQ results and change from baseline
|
30 days, 6, 12, 24 months
|
Primary and primary assisted patency rates
Time Frame: 30 days, 6, 12, 24 months
|
|
30 days, 6, 12, 24 months
|
Primary and secondary sustained clinical improvement rates
Time Frame: 30 days, 6, 12, 24 months
|
|
30 days, 6, 12, 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Vascular Diseases
- Ischemia
- Peripheral Arterial Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- CIP0216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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