NCT07482865 Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
| NCT ID | NCT07482865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-07-08 |
| Primary Completion | 2030-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2026-07-08 with a primary completion date of 2030-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jeong Hoon Yang, MD, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT07482865 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07482865 currently recruiting?
Yes, NCT07482865 is actively recruiting participants. Contact the research team at drone80@hanmail.net for enrollment information.
Where is the NCT07482865 trial being conducted?
This trial is being conducted at Changwon, South Korea, Changwon, South Korea, Incheon, South Korea, Seoul, South Korea and 2 additional locations.
Who is sponsoring the NCT07482865 clinical trial?
NCT07482865 is sponsored by Samsung Medical Center. The principal investigator is Jeong Hoon Yang, MD, PhD at Samsung Medical Center. The trial plans to enroll 500 participants.