The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) Registry: Protocol

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Devices

Background:

• Acute lower limb ischemia (ALLI) is a critical condition threatening limb survival.
• Surgical thromboembolectomy has been the standard treatment, but endovascular techniques are emerging.
• Newly developed endovascular thrombectomy devices may offer improved outcomes for ALLI management.

Purpose of the Study:

• To evaluate the early safety and effectiveness of the Penumbra/Indigo Systems for acute lower limb ischemia.
• To define optimal techniques for using these endovascular thrombectomy devices.
• To gather evidence supporting a shift towards endovascular treatment for ALLI.

Main Methods:

• An interventional prospective trial involving patients diagnosed with ALLI.
• Treatment with the Penumbra/Indigo endovascular thrombectomy devices.
• Primary outcome: technical success of thromboaspiration; Secondary outcomes: safety, primary patency, and limb salvage at 1 month.

Main Results:

• The study is in the recruitment phase, with 150 patients planned for enrollment.
• Analyses will focus on primary and secondary endpoints, including technical success, safety, patency, and limb salvage.
• The final patient is expected to be treated by the end of March 2019.

Conclusions:

• New endovascular thrombectomy devices may improve clinical outcomes in ALLI patients.
• These devices might lead to lower rates of systemic and local complications compared to traditional methods.
• The study aims to better define the value of the Indigo Thrombectomy System, potentially shifting treatment recommendations towards endovascular options.