Chronic Limb IschemiaPhase 2TANGONCT02908035

Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO)

A Phase 2 study testing Temsirolimus and Saline in people with Chronic Limb Ischemia, run by Mercator MedSystems, Inc. at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Chronic Limb Ischemia
What is being tested?: Temsirolimus and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 8 sitesUnited States
Study dates: 3 Mar 2017to Sep 2021
Phase: Phase 2
Are there results?: None posted in the registry

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Screening Criteria:
Age ≥18 years and <90 years
Patient has been informed of the nature of the study, agrees to participate 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 (See Section 12.2) one month preceding and 12 months following study treatment
Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 3, 4 or 5
Life expectancy >1 year in the Investigator's opinion

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Angiographic Criteria:
Target vessel(s) diameter ≥2 mm and ≤8 mm
Single or multiple atherosclerotic lesion(s) ≥70% in at least one below-knee popliteal or tibial target vessel including the tibioperoneal trunk that totals up to no greater than 30 cm in length (with no greater than 5 cm length of contiguous intervening normal artery), with possible extension into the popliteal artery distal to the center of the knee joint space (the P3 segment)
Successful revascularization of the TL with less than 30% residual stenosis, run-off down to the foot and direct in-line flow to any foot wound, if a wound is present at baseline

Who cannot join

Screening Criteria
Patient is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint
Patient unwilling or unlikely to comply with visit schedule
Patients who are 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, chemotherapy, or steroids (however, inhaled steroids for asthma treatment or topical steroid uses are allowed)
Patient has a bilirubin level of >1.5xULN

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Recent (<30 days prior to study procedure) myocardial infarction
Cerebrovascular accident <60 days prior to the study procedure
Planned major (above the ankle) target limb amputation
Active foot infection; however, osteomyelitis in the toes or mild cellulitis around the perimeter of gangrene or small ulcers (<25mm) are not exclusions, but osteomyelitis of the metatarsal or more proximal region would be exclusionary
Inability to receive temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions 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
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
Angiographic/Procedural Criteria
Hemodynamically significant inflow lesion (≥50% DS) or occlusion in the ipsilateral iliac, SFA, or popliteal arteries (P1 and P2) in which there is failure to successfully treat and obtain a <30% residual stenosis post-revascularization, with bailout stenting as needed (in-flow lesions should be treated prior to treating the target lesion)
Target lesion length is >30 cm as measured from proximal normal vessel to distal normal vessel
Total length of lesions treated during the case (including target lesion, inflow lesions, and other non-target lesions) >30 cm
Use of alternative therapy, e.g. radiation therapy, drug-eluting stents (DES) or drug-eluting balloon/drug-coated balloons (DEB/DCB) as part of the target lesion treatment or during the previous 2 months within the target lesion
Previously implanted stent in the TL(s)
Aneurysm in the target vessel
Acute thrombus in the target limb
Failure to cross the TL with a guide wire; however, subintimal wire crossing is allowed
Heavy eccentric or concentric calcification at target lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University Hospital
Cleveland, Ohio, 44106
Denver Veterans Administration Hospital
Denver, Colorado, 80220
Baylor College of Medicine
Houston, Texas, 77030
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
St. Joseph Hospital of Orange Heart and Vascular Center
Orange, California, 92868
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Sanford Research
Sioux Falls, South Dakota, 57101

Other trials in United States

About this study

Official title: TANGO: Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee

Read the detailed description

This is a prospective, multi-center, randomized, dose escalation study to document the effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions below the knee in symptomatic patients with critical limb ischemia (CLI). Up to 60 patients (20 low-dose, 20 high-dose and 20 control) at up to 15 sites in the United States. This study will assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of temsirolimus in reducing intimal hyperplasia, inflammatory markers and composite safety endpoints in patients with clinical evidence of chronic critical limb ischemia after revascularization of one or more angiographically significant lesion(s) in below-knee popliteal or tibial vessels.

Conditions: Chronic Limb Ischemia
Being tested: Temsirolimus, Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TemsirolimusDrug
Also called Torisel
After completion of revascularization therapy and any decision to place stents, patients will be qualified for final enrollment in the study and will be treated with the investigational drug or saline. Investigators will be blinded to assignment.
SalineDrug
After completion of revascularization therapy and any decision to place stents, patients will be qualified for final enrollment in the study and will be treated with the investigational drug or saline. Investigators will be blinded to assignment.

Study groups in NCT02908035
Study group	Role	What they receive
Active Comparator: Temsirolimus Delivery High Dose	Active comparator	High-Dose Group: 0.4 mg/mL temsirolimus (including 20% contrast) Patients qualifying for enrollment will be randomized 2:1 for inclusion in either the treatment (low-dose or high-dose) or the control group. The first 20 patients randomized to treatment will receive low-dose. After the first 30 patients (20 low-dose and 10 control) are enrolled in the trial, enrollment will be held until 30-day safety endpoints are met, at which point the dosage will be escalated to the high dose and the trial will resume, with the remaining 30 patients randomized 2:1 for high-dose or control. Receives: Drug: Temsirolimus
Active Comparator: Temsirolimus Delivery Low Dose	Active comparator	Low-Dose Group: 0.1 mg/mL temsirolimus (including 20% contrast) Patients qualifying for enrollment will be randomized 2:1 for inclusion in either the treatment (low-dose or high-dose) or the control group. The first 20 patients randomized to treatment will receive low-dose. After the first 30 patients (20 low-dose and 10 control) are enrolled in the trial, enrollment will be held until 30-day safety endpoints are met, at which point the dosage will be escalated to the high dose and the trial will resume, with the remaining 30 patients randomized 2:1 for high-dose or control. Receives: Drug: Temsirolimus
Placebo Comparator: Saline Delivery	Placebo comparator	Control Group: Saline/contrast (80% normal saline for injection:20% non-ionic contrast) The first 20 patients randomized to treatment will receive low-dose. After the first 30 patients (20 low-dose and 10 control) are enrolled in the trial, enrollment will be held until 30-day safety endpoints are met, at which point the dosage will be escalated to the high dose and the trial will resume, with the remaining 30 patients randomized 2:1 for high-dose or control. Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom from MALE-POD
Freedome from MALE-POD at 30 days.
Measured: Up to 30 days post-procedure
Transverse-view vessel area loss percentage (TVAL%) of the target lesion
Transverse-view vessel area loss percentage (TVAL%) of the target lesion at 6 months by quantitative vascular angiography (QVA) or prior to any TLR of the target lesion before 6 months.
Measured: Within 6 months post-procedure

Secondary outcomes (7)

Freedom from a composite of all-cause death, MALE and unplanned minor amputation in target limb
Freedom from a composite of all-cause death within 30 days from the index procedure, major adverse limb event (MALE) of the target limb, unplanned minor amputation in the target limb, and clinically driven target lesion revascularization (CD-TLR) within 6 months.
Measured: Up to 30 days post-procedure
Freedom from a composite of death, unplanned minor amputation, clinically driven TLR, and major adverse limb events (MALE)
Freedom from a composite of death, unplanned minor amputation, clinically driven TLR, and major adverse limb events (MALE) up to 12 months from the procedure for all subjects.
Measured: Up to 12 months post-procedure
Freedom from Serious Adverse Events (SAEs)
Freedom from serious adverse events (SAE) to 12 months from the procedure for all subjects.
Measured: Up to 12 months post-procedure
Event-free survival
Event-free survival to 12 months from the procedure for all subjects.
Measured: Up to 12 months post-procedure
Improvement in % diameter stenosis and maximum late lumen loss (LLL) of the target lesion
6-month improvement % diameter stenosis (%DS) of the target lesion (TL) and the maximum late lumen loss for the lesion (LLL) will be assessed by Quantitative Vascular Angiography.
Measured: Up to 6 months post-procedure
Improvement in luminal volume by intravascular ultrasound (IVUS)
6-month improvement in luminal volume as measured by intravascular ultrasound (IVUS) within the TL (subgroup analysis).
Measured: Up to 6 months post-procedure
Composite of major amputation, target vessel occlusion or CD-TLR
A composite at 12 months of freedom from major amputation, target vessel occlusion, or CD-TLR.
Measured: Up to 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 2017Sep 2021

First posted20 Sep 2016 (estimated)
Study start3 Mar 2017
Primary completionSep 2020 (estimated)
Study completionSep 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Limb IschemiaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02908035
Sponsor's protocol ID: CIP0214
Acronym: TANGO
Status last verified: Jun 2020
First submitted: 16 Sep 2016
Last updated: 11 Jun 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Limb Ischemia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TANGO: Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee
ClinicalTrials.gov ID: NCT02908035
Acronym / sponsor ID: TANGO / CIP0214
Conditions: Chronic Limb Ischemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Mercator MedSystems, Inc.Industry (pharma, biotech, devices)
Study start: 3 Mar 2017 (actual)
Primary completion: Sep 2020 (estimated)
Study completion: Sep 2021 (estimated)
First posted: 20 Sep 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Active Comparator: Temsirolimus Delivery High Dose	Active comparator	Drug: TemsirolimusHigh-Dose Group: 0.4 mg/mL temsirolimus (including 20% contrast) Patients qualifying for enrollment will be randomized 2:1 for inclusion in either the treatment (low-dose or high-dose) or the control group. The first 20 patients randomized to treatment will receive low-dose. After the first 30 patients (20 low-dose and 10 control) are enrolled in the trial, enrollment will be held until 30-day safety endpoints are met, at which point the dosage will be escalated to the high dose and the trial will resume, with the remaining 30 patients randomized 2:1 for high-dose or control.
Active Comparator: Temsirolimus Delivery Low Dose	Active comparator	Drug: TemsirolimusLow-Dose Group: 0.1 mg/mL temsirolimus (including 20% contrast) Patients qualifying for enrollment will be randomized 2:1 for inclusion in either the treatment (low-dose or high-dose) or the control group. The first 20 patients randomized to treatment will receive low-dose. After the first 30 patients (20 low-dose and 10 control) are enrolled in the trial, enrollment will be held until 30-day safety endpoints are met, at which point the dosage will be escalated to the high dose and the trial will resume, with the remaining 30 patients randomized 2:1 for high-dose or control.
Placebo Comparator: Saline Delivery	Placebo comparator	Drug: SalineControl Group: Saline/contrast (80% normal saline for injection:20% non-ionic contrast) The first 20 patients randomized to treatment will receive low-dose. After the first 30 patients (20 low-dose and 10 control) are enrolled in the trial, enrollment will be held until 30-day safety endpoints are met, at which point the dosage will be escalated to the high dose and the trial will resume, with the remaining 30 patients randomized 2:1 for high-dose or control.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥18 years and <90 years
Patient has been informed of the nature of the study, agrees to participate 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 (See Section 12.2) one month preceding and 12 months following study treatment
Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 3, 4 or 5
Life expectancy >1 year in the Investigator's opinion

Key exclusion criteria (22 listed)

Screening Criteria
Patient is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint
Patient unwilling or unlikely to comply with visit schedule
Patients who are 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, chemotherapy, or steroids (however, inhaled steroids for asthma treatment or topical steroid uses are allowed)

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
TemsirolimusAlso: ToriselAfter completion of revascularization therapy and any decision to place stents, patients will be qualified for final enrollment in the study and will be treated with the investigational drug or saline. Investigators will be blinded to assignment.	Drug	Active Comparator: Temsirolimus Delivery High Dose, Active Comparator: Temsirolimus Delivery Low Dose
SalineAfter completion of revascularization therapy and any decision to place stents, patients will be qualified for final enrollment in the study and will be treated with the investigational drug or saline. Investigators will be blinded to assignment.	Drug	Placebo Comparator: Saline Delivery

Primary outcome

Freedom from MALE-POD
Time frame: Up to 30 days post-procedure
Freedome from MALE-POD at 30 days.
Transverse-view vessel area loss percentage (TVAL%) of the target lesion
Time frame: Within 6 months post-procedure
Transverse-view vessel area loss percentage (TVAL%) of the target lesion at 6 months by quantitative vascular angiography (QVA) or prior to any TLR of the target lesion before 6 months.

7 secondary outcomes

Freedom from a composite of all-cause death, MALE and unplanned minor amputation in target limb
Time frame: Up to 30 days post-procedure
Freedom from a composite of death, unplanned minor amputation, clinically driven TLR, and major adverse limb events (MALE)
Time frame: Up to 12 months post-procedure
Freedom from Serious Adverse Events (SAEs)
Time frame: Up to 12 months post-procedure
Event-free survival
Time frame: Up to 12 months post-procedure
Improvement in % diameter stenosis and maximum late lumen loss (LLL) of the target lesion
Time frame: Up to 6 months post-procedure
Improvement in luminal volume by intravascular ultrasound (IVUS)
Time frame: Up to 6 months post-procedure
Composite of major amputation, target vessel occlusion or CD-TLR
Time frame: Up to 12 months post-procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Individual participant dataSharing planned: Yes

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temsirolimus and Saline in people with Chronic Limb Ischemia, run by Mercator MedSystems, Inc. at 8 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 10 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from MALE-POD (time frame: Up to 30 days post-procedure). 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?

On the ClinicalTrials.gov record for NCT02908035.

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 11 Jun 2020.