Status unknownNCT02908035TANGOUpdated Jun 11, 2020

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

A Phase 2 interventional study of Temsirolimus and Saline in Chronic Limb Ischemia, sponsored by Mercator MedSystems, Inc.. Status unknown at 8 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Mercator MedSystems, Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study summary

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 studied

Chronic Limb Ischemia

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Ischemia 2,058

In context

Ischemia

2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 1,359 interventional studies indexed under Ischemia.

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Lead sponsor

Mercator MedSystems, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 100 participants (estimated)

Study arms

Active comparator
Active Comparator: Temsirolimus Delivery High Dose
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.
Drug: Temsirolimus
Active comparator
Active Comparator: Temsirolimus Delivery Low Dose
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.
Drug: Temsirolimus
Placebo comparator
Placebo Comparator: Saline Delivery
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.
Drug: Saline

Interventions

DrugTemsirolimus
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.
Also known as: Torisel
DrugSaline
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.

What researchers measure

Primary outcomes

Freedom from MALE-POD
Freedome from MALE-POD at 30 days.
Time frame: 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.
Time frame: Within 6 months post-procedure

Secondary outcomes

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.
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)
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.
Time frame: 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.
Time frame: Up to 12 months post-procedure
Event-free survival
Event-free survival to 12 months from the procedure for all subjects.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 12 months post-procedure

Study locations

8 sites

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

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02908035
Lead sponsor: Mercator MedSystems, Inc.
Responsible party: Sponsor
First posted: Sep 20, 2016
Start date: Mar 3, 2017
Primary completion: Sep 2020 (estimated)
Completion: Sep 2021 (estimated)
Last update: Jun 11, 2020

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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