Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support (PERFUSE-MCS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocarditis; Congestive Heart Failure; Cardiogenic Shock; Acute Limb Ischemia; Acute Myocardial Infarction of Inferior Wall
• Intervention / Treatment: Procedure: Distal perfusion catheter insertion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joo Myung Lee, MD, MPH, PhD; Phone Number: 82234102575; Email: drone80@hanmail.net
• Study Contact Backup: Name: Jeong Hoon Yang, MD, PhD; Phone Number: 82234102575; Email: jhysmc@gmail.com

Study Locations

• South Korea
  • Changwon, South Korea
    • Gyeongsang National University Changwon Hospital
    • Contact: Jong-Hwa Ahn, MD, PhD; Email: jonghwaahn@naver.com
    • Principal Investigator: Jong-Hwa Ahn, MD, PhD
  • Changwon, South Korea
    • Samsung Medical Center Changwon Hospital
    • Contact: Ik-Hyun Park, MD, PhD; Email: ionoeval@gmail.com
    • Principal Investigator: Ik-Hyun Park, MD, PhD
  • Incheon, South Korea
    • Kwandong University Intl. ST. Mary's Hospital
    • Contact: Hyung-Bok Park, MD, PhD; Email: hyungbok7@gmail.com
    • Principal Investigator: Hyung-Bok Park, MD, PhD
  • Seoul, South Korea, 06351
    • Samsung Medical Center
    • Contact: Joo Myung Lee, MD, MPH, PhD; Phone Number: 0234102575; Email: drone80@hanmail.net
    • Contact: Jeong Hoon Yang, MD, PhD; Phone Number: 0234102575; Email: jhysmc@gmail.com
    • Principal Investigator: Jeong Hoon Yang, MD, PhD
    • Sub-Investigator: Joo Myung Lee, MD, PhD
    • Sub-Investigator: Ji Hyun Cha, MD
  • Seoul, South Korea
    • Korea University Anam Hospital
    • Contact: Yonghoon Shin, MD, PhD; Email: fibrillary@gmail.com
    • Principal Investigator: Yonghoon Shin, MD, PhD
  • Seoul, South Korea
    • Eunpyeong St. Mary's Hospital
    • Contact: Suk Min Seo, MD, PhD; Email: ssm530@catholic.ac.kr
    • Principal Investigator: Suk Min Seo, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Routine distal perfusion catheter insertion group; 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; Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.; Other Names: DPC insertion
Active Comparator: Provisional distal perfusion catheter insertion group; 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.; Other Names: DPC insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major limb ischemia requiring intervention	Major limb ischemia requiring intervention	within 30 days from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Time to all-cause mortality	within 90 days from randomization
Cardiovascular mortality	Time to cardiovascular mortality	within 90 days from randomization
Successful weaning of mechanical circulatory device	Successful weaning of mechanical circulatory device	within 90 days from randomization
Bleeding	Bleeding defined by BARC type 2,3, or 5	within 90 days from randomization
Systemic thromboembolism other than stroke during MCS	Systemic thromboembolism other than stroke during MCS	within 90 days from randomization
Cerebrovascular accidents	Cerebrovascular accidents (ischemic stroke or hemorrhagic stroke)	within 90 days from randomization
Rates of renal replacement therapy during index hospitalization	Rates of renal replacement therapy during index hospitalization	within 30 days from randomization
Duration of MCS during index hospitalization	Duration of MCS during index hospitalization	within 30 days from randomization
Duration of hospital stay during index hospitalization	Duration of hospital stay during index hospitalization	within 30 days from randomization
Duration of mechanical ventilation during index hospitalization	Duration of mechanical ventilation during index hospitalization	within 30 days from randomization

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Korea University Anam Hospital; Samsung Changwon Hospital; Gyeongsang National University Changwon Hospital; Eunpyeong St. Mary's Hospital; Kwandong University Intl. ST. Mary's Hospital
• Investigators: Principal Investigator: Jeong Hoon Yang, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Congestive Heart Failure; Cardiogenic Shock; Limb ischemia; Distal perfusion catherter
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Cardiomyopathies; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Heart Failure; Myocarditis; Shock, Cardiogenic; Inferior Wall Myocardial Infarction
• Other Study ID Numbers: SMC0108884119023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.
• IPD Sharing Time Frame: After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No