Distal perfusion catheter insertion: Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.
Study summary
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.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Major limb ischemia requiring intervention — within 30 days from randomization Major limb ischemia requiring intervention
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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