Peripheral Artery DiseasePhase 3TANGO-3NCT04433572
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
A Phase 3 study testing Temsirolimus in people with Peripheral Artery Disease and Critical Limb Ischemia, run by Mercator MedSystems, Inc. at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Critical Limb Ischemia
- What is being tested?
- Temsirolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2025to 1 Aug 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-procedural:
- Participant has signed and dated informed consent, is capable of understanding the nature, significance and implications of the clinical trial, and is willing to comply with all study procedures and follow-up visits for the duration of the study.
- Participant is male or female, aged 18 years or older.
- If participant is female and of reproductive potential: agreement to use a highly effective contraception (abstinence is acceptable) for at least 90 days after study treatment.
- Participant has severe claudication (Rutherford 3) or chronic limb-threatening ischemia (CLTI) (Rutherford 4-5) in the Target Limb.
- Angiographic/Procedural:
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- Participant has up to two de novo or restenotic Qualified Target Lesions meeting the following criteria, each based on the Investigator's visual assessment. Target Lesions should be considered separate if they are located in separate vessels (not in the same blood path) or have more than 10 cm intervening normal artery.
- Diameter
- ≥70% diameter stenosis anywhere within the Target Lesion or ≥50% diameter stenosis spanning at least 10 cm of length.
- Reference (normal) vessel diameter ≥2 mm and ≤8 mm. Location
- Any lesion chosen as a Target Lesion is in or spans at least one below-knee popliteal (P3 segment), tibial, or peroneal artery and is a culprit for dominant disease symptoms based on Investigator's assessment.
- ≥50% of the Target Lesion length is below the knee joint space (<50% of Target Lesion length may extend above the midline of the knee joint space).
- ≥10 mm away from any previously placed stent or graft.
- A Target Lesion may cross an ostium of another artery (i.e. pass a bifurcation) but may only include one of the two branches. (Notes: Investigator should choose the dominant lesion for Target Lesion. Bifurcated lesions should be excluded, but if a lesion in a bifurcating vessel is separate from a Target Lesion based on intervening normal artery from which a proximal reference diameter can be measured, it may be treated as a second Target Lesion.) Length
- ≤30 cm in cumulative length from most proximal to most distal normal segment bounding the Target Lesion(s).
- A single Target Lesion may be comprised of multiple lesions or multifocal lesions (i.e. tandem lesions) if there is no continuous normal segment >10cm in length within the Target Lesion.
- Target Lesion may be in a vessel with another Target Lesion or above-knee non-target lesion if it is >10 cm away.
- Participant receives successful revascularization, based on the following Investigator visual assessments:
- Target Lesion and any treated non-target lesion in a Target Vessel or its inflow has <30% residual stenosis, outflow has <50% stenosis, and there is no flow-limiting dissection or perforation after treatment in an inflow vessel or Target Vessel.
- Participant has distal run-off into the foot with a patent named pedal artery.
Who cannot join
- Pre-procedural:
- Participant is already enrolled in another clinical study of systemic or local vascular drug therapy or a vascular device study that has not completed its primary endpoint, including prior enrollment in this study.
- Participant is pregnant, nursing, or planning to become pregnant during the first 12 months after their enrollment in the study.
- Participant has presence of another anatomic or comorbid condition, or other medical, social, or psychological condition that, in the investigator's opinion, could limit the participant's ability to complete the clinical investigation or comply with follow-up requirements.
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- Participant has a life expectancy of ≤1 year.
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- Participant received in the prior 2 months, is currently receiving, or is planned to receive systemic immunosuppressive therapy, immunotherapy or chemotherapy.
- Participant has platelet count < 100,000 cells per microliter or > 700,000 cells per microliter, or hemoglobin < 7.5 g/dL.
- Participant is unable to receive H1 antihistamine, temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions except for contrast allergies for which adequate prophylaxis may be used.
- Participant has a CNS tumor.
- Participant has had a myocardial infarction within the 30 days prior to study procedure.
- Participant has had a cerebrovascular accident within the 90 days prior to the study procedure.
- Participant has had an intracerebral hemorrhage within the 1 year prior to the study procedure.
- Participant has had any vascular surgical or endovascular procedure performed within the 30 days prior to the Index Procedure or planned within the 30 days after the Index Procedure; allowable exceptions to this exclusion include the following:
- Procedures performed during the same setting as the Index Procedure.
- Prior staged revascularization in the Target Limb but not the Target Lesion (e.g. for inflow revascularization) within the 30 days prior to the Index Procedure.
- Participant has a patent, previously implanted bypass graft within 3 cm of the Target Lesion.
- Participant is bedridden or unable to walk (with assistance is acceptable). Participants in wheelchair who are able to mobilize on their own can be enrolled.
- Participant has a planned major (above the ankle) amputation in the Target Limb.
- Participant has had any amputation to the ipsilateral extremity other than the toe or forefoot, or has had major amputation to the contralateral extremity < 1 year prior to index procedure and is not independently ambulating.
- Participant has signs or symptoms of advanced limb infection or septicemia (fever > 38.5℃, white blood cell count > 15,000 cells per microliter, hypotension) at the time of assessment. Osteomyelitis of the phalanges or metatarsal heads or cellulitis of the foot amenable to treatment with IV antibiotics at the time of revascularization is acceptable.
- Participant has extensive tissue loss salvageable only with complex foot reconstruction or non-traditional amputations (e.g. Chopart or Lisfranc extending more proximal than a traditional transmetatarsal amputation), including any of the following conditions:
- Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis limited to the phalanges or metatarsal heads is acceptable for enrollment.
- Any of the following involving the plantar skin of the forefoot, midfoot, or heel that cannot be effectively removed with a transmetatarsal amputation:
- Gangrene. ii) Deep ulcer (penetrating deeper than the dermis to subcutaneous structures involving facia, muscle or tendon).
- Large shallow ulcer (not penetrating deeper than the dermis and >3cm in any measurement).
- Full thickness heel ulcer with or without calcaneal involvement. d) Any wound with calcaneal bone involvement. e) Dorsal wound with extensive necrosis requiring planned amputation more proximal than a transmetatarsal amputation.
- Wounds that are deemed to be neuropathic or non-ischemic in nature. g) Wounds that would require flap coverage or complex wound management for large soft tissue defect.
- Participant has a bilirubin level of >1.5xULN (upper limit of normal range).
- Participant has an estimated glomerular filtration rate (eGFR) less than 30 mL/min, except for patients with end stage renal disease on stable, chronic dialysis.
- Angiographic/Procedural:
- Participant has severe, advanced atherosclerotic peripheral artery disease (treated or left untreated) in the Target Limb which, in the opinion of the Investigator, has limited likelihood of a successful outcome.
- Participant has stenotic lesions, flow limiting dissection, or complication in any of the inflow or outflow vessels in the flow path of the Target Lesion, left untreated or after treatment, with residual stenosis >30% based on the Investigator's visual assessment.
- Participant receives or has received external radiation therapy to the target limb, vascular brachytherapy, cryotherapy, or drug-coated balloon (DCB) as part of the Target Lesion treatment during the index procedure or previous 6 months.
- Participant has been treated with a non-resorbable stent/scaffold in the Target Lesion in a prior setting (i.e. in-stent restenosis) or a bioresorbable scaffold in the Target Lesion in the previous 12 months.
- Participant has a severe (Type C or worse) dissection within the Target Lesion after revascularization but prior to Bullfrog drug delivery.
- Participant has an untreated aneurysm in the iliac, common femoral, superficial femoral, popliteal, or Target Vessel of the ipsilateral limb.
- Participant has visible thrombus requiring thrombolysis, percutaneous thrombectomy, or other treatment for acute limb ischemia of the Target Limb.
- Participant has angiographic evidence of thromboembolism or atheroembolism in the ipsilateral extremity upon completion of the intervention. (Pre- and post-angiographic imaging must confirm the absence of emboli in the distal anatomy.)
- Participant has a Target Lesion that cannot be crossed with a guide wire; however, subintimal wire crossing is allowed.
- Participant has heavy calcification at Target Lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall across the majority of the Target Lesion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UT Southwestern
Dallas, Texas, 75235
- Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
About this study
Official title: 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.
Read the detailed 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 2:1 and treated with the investigational drug or placebo, respectively. 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.
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia
- Being tested
- Temsirolimus, Saline placebo
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
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.
Saline placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Active comparator | Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization Receives: Drug: Temsirolimus |
| Placebo | Placebo comparator | Saline placebo delivered to adventitia and perivascular tissue after primary revascularization Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Cinical Relevant Target Lesion Failure
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
Measured: 6 Months
MALE + POD
Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)
Measured: 30 Days
Secondary outcomes (4)
Rate of clinically relevant restenosis (CRR)
Superiority of treatment vs. control group in the rate of clinically relevant restenosis (CRR)
Measured: 6 months
Freedom from target lesion failure (TLF)
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
Measured: 6 Months
Freedom from clinically relevant target lesion failure (CR-TLF)
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
Measured: 12 Months
Rate of clinically relevant restenosis (CRR)
Superiority of treatment vs. control group in the rate of clinically relevant restenosis (CRR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start30 Jul 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization will be stratified for Rutherford 3 and for Rutherford 4/5 participants such that each strata will be randomized 2:1. Block randomization will also be stratified by site such that each site will be assigned a 2:1 randomization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercator MedSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433572
- Sponsor's protocol ID
- CIP0216
- Acronym
- TANGO-3
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2020
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No, there is not a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04433572
- Acronym / sponsor ID
- TANGO-3 / CIP0216
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mercator MedSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2032 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 2:1 and treated with the investigational drug or placebo, respectively. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Block randomization will be stratified for Rutherford 3 and for Rutherford 4/5 participants such that each strata will be randomized 2:1. Block randomization will also be stratified by site such that each site will be assigned a 2:1 randomization.
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Active comparator | Drug: TemsirolimusTemsirolimus delivered to adventitia and perivascular tissue after primary revascularization |
| Placebo | Placebo comparator | Drug: Saline placeboSaline placebo delivered to adventitia and perivascular tissue after primary revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participant has signed and dated informed consent, is capable of understanding the nature, significance and implications of the clinical trial, and is willing to comply with all study procedures and follow-up visits for the duration of the study.
- Participant is male or female, aged 18 years or older.
- If participant is female and of reproductive potential: agreement to use a highly effective contraception (abstinence is acceptable) for at least 90 days after study treatment.
- Participant has severe claudication (Rutherford 3) or chronic limb-threatening ischemia (CLTI) (Rutherford 4-5) in the Target Limb.
- Participant has up to two de novo or restenotic Qualified Target Lesions meeting the following criteria, each based on the Investigator's visual assessment. Target Lesions should be considered separate if they are located in separate vessels (not in the same blood path) or have more than 10 cm intervening normal artery.
Key exclusion criteria (41 listed)
- Participant is already enrolled in another clinical study of systemic or local vascular drug therapy or a vascular device study that has not completed its primary endpoint, including prior enrollment in this study.
- Participant is pregnant, nursing, or planning to become pregnant during the first 12 months after their enrollment in the study.
- Participant has presence of another anatomic or comorbid condition, or other medical, social, or psychological condition that, in the investigator's opinion, could limit the participant's ability to complete the clinical investigation or comply with follow-up requirements.
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- Participant has a life expectancy of ≤1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temsirolimus0.1 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. | Drug | Temsirolimus |
| Saline placeboSaline 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. | Drug | Placebo |
Primary outcome
Freedom from Cinical Relevant Target Lesion Failure
Time frame: 6 Months
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
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)
4 secondary outcomes
Rate of clinically relevant restenosis (CRR)
Time frame: 6 months
Freedom from target lesion failure (TLF)
Time frame: 6 Months
Freedom from clinically relevant target lesion failure (CR-TLF)
Time frame: 12 Months
Rate of clinically relevant restenosis (CRR)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No. No, there is not a plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temsirolimus in people with Peripheral Artery Disease and Critical Limb Ischemia, run by Mercator MedSystems, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirk Seward, PhD ((510) 614-4555, kseward@mercatormed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Cinical Relevant Target Lesion Failure (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.