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ClinicalTrials.gov ID

NCT07482865

Lead Sponsor

Samsung Medical CenterOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

500Estimated

Last Update Posted

Mar 20, 2026Actual

Start Date

May 1, 2026Estimated

Primary Completion Date

Aug 31, 2030Estimated

Completion Date

Oct 31, 2030Estimated

Official Title

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

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.

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.

• Cardiogenic Shock
• Acute Myocardial Infarction of Inferior Wall
• Congestive Heart Failure
• Myocarditis
• Acute Limb Ischemia

• Distal perfusion catheter insertion

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Korea University Anam HospitalOTHER

Gyeongsang National University Changwon HospitalOTHER

Samsung Changwon HospitalOTHER

Eunpyeong St. Mary's HospitalOTHER

Kwandong University Intl. ST. Mary's HospitalUNKNOWN

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ssm530@catholic.ac.kr

fibrillary@gmail.com