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

ConditionsCardiogenic ShockAcute Myocardial Infarction of Inferior WallCongestive Heart FailureMyocarditisAcute Limb Ischemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Distal perfusion catheter insertion

    Procedure/Surgery

    Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Routine distal perfusion catheter insertion groupExperimental treatment 1 intervention
Group B: Provisional distal perfusion catheter insertion groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major limb ischemia requiring intervention

Major limb ischemia requiring intervention

Time frame
within 30 days from randomization

Secondary outcomes

1

All-cause mortality

Time to all-cause mortality

Time frame
within 90 days from randomization
2

Cardiovascular mortality

Time to cardiovascular mortality

Time frame
within 90 days from randomization
3

Successful weaning of mechanical circulatory device

Successful weaning of mechanical circulatory device

Time frame
within 90 days from randomization
4

Bleeding

Bleeding defined by BARC type 2,3, or 5

Time frame
within 90 days from randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Korea University Anam Hospital

Collaborator

Gyeongsang National University Changwon Hospital

Collaborator

Samsung Changwon Hospital

Collaborator

Eunpyeong St. Mary's Hospital

Collaborator

Kwandong University Intl. ST. Mary's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: