Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support

Starting soon · Not applicable

Conditions studied: Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall, Congestive Heart Failure, Myocarditis, Acute Limb Ischemia

In brief

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.

Key facts

Study ID

NCT07482865

Run by

Samsung Medical Center

People needed

500

Starts

2026-05-01

Expected to finish

2030-10-31

Last updated by the study team

2026-03-20

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Previous history if femoral-femoral bypass grafting or femoral-popliteal bypass grafting
• Previous history of limb amputation
• Unwilling or unable to obtain informed consent from the participant or legally authorized representative

Where it is running

• Gyeongsang National University Changwon Hospital — Changwon, South Korea
• Samsung Medical Center Changwon Hospital — Changwon, South Korea
• Kwandong University Intl. ST. Mary's Hospital — Incheon, South Korea
• Samsung Medical Center — Seoul, South Korea
• Eunpyeong St. Mary's Hospital — Seoul, South Korea
• Korea University Anam Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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