An interventional study of Distal perfusion catheter insertion in Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall and Congestive Heart Failure, sponsored by Samsung Medical Center. Recruiting at 6 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
Acute limb ischemia is a well-recognized vascular complication following peripheral mechanical circulatory support (MCS) including veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or a percutaneous microaxial ventricular assist device (Impella) via femoral arterial cannulation, with reported incidence rates ranging up to 10-30% of patients. Distal perfusion catheter (DPC) has been introduced as a strategy to restore antegrade flow distal to the femoral arterial cannula, aiming to mitigate ischemic complications by augmenting perfusion through antegrade flow into the superficial femoral artery.
Current practice guidance from the Extracorporeal Life Support Organization (ELSO) supports the use of ipsilateral DPC placement at the time of peripheral VA-ECMO cannulation to reduce the risk of limb ischemia and recommends monitoring for adequate flow using Doppler or near-infrared spectroscopy (NIRS). However, these recommendations are predominantly based on observational studies and expert consensus, and do not stem from randomized controlled trial evidence. Current expert consensus and related guidelines describe that routine prophylactic DPC insertion should be considered in patients undergoing VA-ECMO as Class IIa (Level of evidence B) recommendation.
Several observational cohort studies have associated routine prophylactic DPC with reduced limb ischemia compared with no DPC placement, yet these are limited by confounding bias and variability in clinical practice patterns. Retrospective data suggested that delayed or rescue insertion after onset of limb ischemia may be less effective at preventing major ischemic sequelae than earlier DPC insertion strategies.
Given the absence of robust evidence from randomized controlled trial, it remains uncertain whether a strategy of routine prophylactic DPC insertion would be superior over a provisional DPC insertion guided by clinical monitoring in terms of limb ischemia reduction, limb-related morbidity, duration of MCS, and other clinical outcomes including in-hospital mortality.
In this regard, Routine versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support (PERFUSE-MCS) trial was designed to compare clinical outcomes between routine DPC insertion versus provisional DPC insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing MCS through femoral artery approach.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 500 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the routine DPC insertion group, DPC insertion will be performed within 1 hour from MCS or from transfer from outside hospital under MCS. Fluoroscopy-guided DPC insertion will be used. In case of fluoroscopy is not available or patient's hemodynamic condition precludes transfer of patient to catheterization laboratory, bed-side ultrasound-guided DPC will be permitted.
Procedure: Distal perfusion catheter insertion
In the provisional distal perfusion catheter insertion group, DPC insertion will be performed at the time of symptom or sign of limb ischemia. Fluoroscopy-guided DPC insertion will be used. In case of fluoroscopy is not available or patient's hemodynamic condition precludes transfer of patient to catheterization laboratory, bed-side ultrasound-guided DPC will be permitted.
Procedure: Distal perfusion catheter insertion
Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.
Also known as: DPC insertion
Major limb ischemia requiring intervention
Major limb ischemia requiring intervention
Time frame: within 30 days from randomization
All-cause mortality
Time to all-cause mortality
Time frame: within 90 days from randomization
Cardiovascular mortality
Time to cardiovascular mortality
Time frame: within 90 days from randomization
Successful weaning of mechanical circulatory device
Successful weaning of mechanical circulatory device
Time frame: within 90 days from randomization
Bleeding
Bleeding defined by BARC type 2,3, or 5
Time frame: within 90 days from randomization
Systemic thromboembolism other than stroke during MCS
Systemic thromboembolism other than stroke during MCS
Time frame: within 90 days from randomization
Cerebrovascular accidents
Cerebrovascular accidents (ischemic stroke or hemorrhagic stroke)
Time frame: within 90 days from randomization
Rates of renal replacement therapy during index hospitalization
Rates of renal replacement therapy during index hospitalization
Time frame: within 30 days from randomization
Duration of MCS during index hospitalization
Duration of MCS during index hospitalization
Time frame: within 30 days from randomization
Duration of hospital stay during index hospitalization
Duration of hospital stay during index hospitalization
Time frame: within 30 days from randomization
Duration of mechanical ventilation during index hospitalization
Duration of mechanical ventilation during index hospitalization
Time frame: within 30 days from randomization
Plan to share: Yes — After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.
Access criteria: Request should be made by e-mail to Dr. Joo Myung Lee (drone80@hanmail.net) or Dr. Jeong Hoon Yang (jhysmc@gmail.com).
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Aug 2030, 49 months after the start.
Of 49 non-industry interventional studies with no phase under Shock, Cardiogenic, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 49 months is above that.
Counting every sponsor, half of 53 studies reached it within 39 months; a quarter within 24 and three quarters within 55.
Start moved once since we started tracking on Sep 25, 2026: May 2026 → Jul 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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