NCT02908035

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mercator MedSystems, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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).

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

Interventions

Type	Name	Description
DRUG	Temsirolimus	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.
DRUG	Saline	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.

Timeline

• Start date: 2017-03-03
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2016-09-20
• Last updated: 2020-06-11

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study