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โ† Trials
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Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support

RecruitingNAAges 19 Years - anyAllSamsung Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Distal perfusion catheter insertion
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Where

6 sites
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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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