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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011941

Enrollment

500

Registered

2026-05-07

Start date

2026-05-25

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : This study compares two strategies for the timing of distal perfusion catheter (DPC) placement in patients undergoing mechanical circulatory support (MCS) via the femoral artery. R

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Aged 19 years or older. ? Patients with cardiogenic shock requiring mechanical circulatory support (MCS) via the femoral artery. ? Patients who understand the risks and benefits of distal perfusion catheter (DPC) insertion and have voluntarily signed (or had a legal representative sign) the informed consent form prior to the procedure. ? If the research subject is unable to provide informed consent due to altered consciousness from shock, endotracheal intubation, or sedation procedures, a legal representative may sign the consent form prior to the relevant procedure

Exclusion criteria

Exclusion criteria: ? Evidence of overt acute limb ischemia symptoms or signs immediately following mechanical circulatory support insertion. ? Patients at high risk of bleeding in whom invasive procedures are impossible due to severe coagulopathy. ? Patients who are pregnant, breastfeeding, or of childbearing potential. ? Patients with irreversible limb ischemia requiring interventional or surgical correction at the time of mechanical circulatory support application. ? Patients with a history of femoro-femoral artery bypass or femoro-popliteal artery bypass. ? Patients with a history of major limb amputation. ? Patients who refuse to participate in the study or from whom it is difficult to obtain informed consent from either the patient or their legal representative.

Design outcomes

Primary

Measure	Time frame
Major limb ischemia requiring intervention within 30 days from randomization	—

Secondary

Measure	Time frame
Cardiovascular mortality within 90 days;Cardiovascular mortality within 90 days;Successful weaning of mechanical circulatory support (MCS) within 90 days;Bleeding Academic Research Consortium [BARC] type 2, 3, or 5;Systemic thromboembolism excluding stroke during mechanical circulatory support;All strokes (ischemic or hemorrhagic);Rates of renal replacement therapy during hospitalization;Duration of mechanical circulatory support during hospitalization (days);Total length of hospital stay (days);Duration of mechanical ventilation during hospitalization (days)	—

Measure

Time frame

Cardiovascular mortality within 90 days;Cardiovascular mortality within 90 days;Successful weaning of mechanical circulatory support (MCS) within 90 days;Bleeding Academic Research Consortium [BARC] type 2, 3, or 5;Systemic thromboembolism excluding stroke during mechanical circulatory support;All strokes (ischemic or hemorrhagic);Rates of renal replacement therapy during hospitalization;Duration of mechanical circulatory support during hospitalization (days);Total length of hospital stay (days);Duration of mechanical ventilation during hospitalization (days)

—

Countries

Korea, Republic of

Contacts

Public ContactJeong Hoon yang

Samsung Medical Center

jhysmc@gmail.com+82-2-2008-4284

Outcome results