A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between routine distal perfusion catheter (DPC) insertion versus provisional distal perfusion catheter (DPC) insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing mechanical circulatory support (MCS) through femoral artery approach.
Patients aged 19 years old
Cardiogenic shock requiring mechanical circulatory support through femoral artery approach
Subject who can verbally confirm understandings of risks and benefits of receiving distal perfusion catheter insertion and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Under the critically-ill clinical circumstance (unclear consciousness of patient), legally authorized representative can provide written informed consent prior to any study related procedure.
Apparent symptoms and sign of acute limb ischemia immediately after mechanical circulatory support insertion
Significant coagulopathy precluding invasive procedure due to high risk of bleeding
Pregnant women, women with potential childbearing, or lactating women
Irreversible limb ischemia requiring interventional procedures or surgery at the time of MCS insertion
Samsung Medical Center
Lead sponsor
Korea University Anam Hospital
Collaborator
Gyeongsang National University Changwon Hospital
Collaborator
Samsung Changwon Hospital
Collaborator
Eunpyeong St. Mary's Hospital
Collaborator
Kwandong University Intl. ST. Mary's Hospital
Collaborator