Routine versus provisional distal perfusion catheter placement during mechanical circulatory support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, open-label, randomized controlled trial comparing routine distal perfusion catheter (DPC) insertion to provisional DPC insertion in patients receiving femoral artery–based mechanical circulatory support. It targets reducing signs of acute limb ischemia and related complications. The trial builds on observational data and guidelines suggesting DPC use, but seeks randomized evidence to guide practice. Eligible adults with cardiogenic shock requiring femoral MCS are randomized to either routine prophylactic DPC or provisional DPC, with outcomes including limb perfusion and ischemia events. The study is conducted at multiple Korean centers with Samsung Medical Center as lead sponsor. Participation requires informed consent from the patient or a legally authorized representative when the patient is critically ill.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Samsung Medical Center
  Seoul, South Korea Recruiting
• Gyeongsang National University Changwon Hospital
  Changwon, South Korea Not yet recruiting
• Samsung Medical Center Changwon Hospital
  Changwon, South Korea Not yet recruiting
• Kwandong University Intl. ST. Mary's Hospital
  Incheon, South Korea Not yet recruiting
• Eunpyeong St. Mary's Hospital
  Seoul, South Korea Not yet recruiting
• Korea University Anam Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Principal investigator: Jeong Hoon Yang, MD, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD
• Email: drone80@hanmail.net
• Phone: 82234102575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.