Cardiogenic ShockPERFUSE-MCSNCT07482865
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
A study testing Distal perfusion catheter insertion in people with Cardiogenic Shock and Acute Myocardial Infarction of Inferior Wall, run by Samsung Medical Center at 6 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall, Congestive Heart Failure
- What is being tested?
- Distal perfusion catheter insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 8 Jul 2026to 31 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Not yet recruiting
Gyeongsang National University Changwon Hospital
Changwon
Jong-Hwa Ahn, MD, PhD, jonghwaahn@naver.com
Jong-Hwa Ahn, MD, PhD
- Not yet recruiting
Samsung Medical Center Changwon Hospital
Changwon
Ik-Hyun Park, MD, PhD, ionoeval@gmail.com
Ik-Hyun Park, MD, PhD
- Not yet recruiting
Kwandong University Intl. ST. Mary's Hospital
Incheon
Hyung-Bok Park, MD, PhD, hyungbok7@gmail.com
Hyung-Bok Park, MD, PhD
- Recruiting
Samsung Medical Center
Seoul, 06351
Joo Myung Lee, MD, MPH, PhD, 0234102575, drone80@hanmail.net
Jeong Hoon Yang, MD, PhD, 0234102575, jhysmc@gmail.com
- Not yet recruiting
Eunpyeong St. Mary's Hospital
Seoul
Suk Min Seo, MD, PhD, ssm530@catholic.ac.kr
Suk Min Seo, MD, PhD
- Not yet recruiting
Korea University Anam Hospital
Seoul
Yonghoon Shin, MD, PhD, fibrillary@gmail.com
Yonghoon Shin, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall, Congestive Heart Failure, Myocarditis, Acute Limb Ischemia
- Being tested
- Distal perfusion catheter insertion
- Keywords
- Cardiogenic Shock, Distal perfusion catherter, Acute Myocardial Infarction, Congestive Heart Failure, Limb ischemia
- Medical subject headings
- Shock, Cardiogenic, Inferior Wall Myocardial Infarction, Heart Failure, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal perfusion catheter insertionProcedure or surgery
Also called DPC insertion
Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Routine distal perfusion catheter insertion group | Experimental | 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. Receives: Procedure: Distal perfusion catheter insertion |
| Provisional distal perfusion catheter insertion group | Active comparator | 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. Receives: Procedure: Distal perfusion catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major limb ischemia requiring intervention
Major limb ischemia requiring intervention
Measured: within 30 days from randomization
Secondary outcomes (10)
All-cause mortality
Time to all-cause mortality
Measured: within 90 days from randomization
Cardiovascular mortality
Time to cardiovascular mortality
Measured: within 90 days from randomization
Successful weaning of mechanical circulatory device
Successful weaning of mechanical circulatory device
Measured: within 90 days from randomization
Bleeding
Bleeding defined by BARC type 2,3, or 5
Measured: within 90 days from randomization
Systemic thromboembolism other than stroke during MCS
Systemic thromboembolism other than stroke during MCS
Measured: within 90 days from randomization
Cerebrovascular accidents
Cerebrovascular accidents (ischemic stroke or hemorrhagic stroke)
Measured: within 90 days from randomization
Rates of renal replacement therapy during index hospitalization
Rates of renal replacement therapy during index hospitalization
Measured: within 30 days from randomization
Duration of MCS during index hospitalization
Duration of MCS during index hospitalization
Measured: within 30 days from randomization
Duration of hospital stay during index hospitalization
Duration of hospital stay during index hospitalization
Measured: within 30 days from randomization
Duration of mechanical ventilation during index hospitalization
Duration of mechanical ventilation during index hospitalization
Measured: within 30 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start8 Jul 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multi-center, open label, randomized controlled, superiority trial 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Gyeongsang National University Changwon Hospital, Samsung Changwon Hospital, Eunpyeong St. Mary's Hospital, Kwandong University Intl. ST. Mary's Hospital
- Responsible party
- Principal investigator, Jeong Hoon Yang, Samsung Medical Center
- Investigators
- Jeong Hoon Yang, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482865
- Sponsor's protocol ID
- SMC0108884119023
- Acronym
- PERFUSE-MCS
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
- ClinicalTrials.gov ID
- NCT07482865
- Acronym / sponsor ID
- PERFUSE-MCS / SMC0108884119023
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall, Congestive Heart Failure, Myocarditis, Acute Limb Ischemia
- Keywords
- Cardiogenic Shock, Distal perfusion catherter, Acute Myocardial Infarction, Congestive Heart Failure, Limb ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Gyeongsang National University Changwon Hospital, Samsung Changwon Hospital, Eunpyeong St. Mary's Hospital, Kwandong University Intl. ST. Mary's Hospital
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multi-center, open label, randomized controlled, superiority trial 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.
| Arm | Type | Receives |
|---|---|---|
| Routine distal perfusion catheter insertion group | Experimental | Procedure: Distal perfusion catheter insertionIn 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. |
| Provisional distal perfusion catheter insertion group | Active comparator | Procedure: Distal perfusion catheter insertionIn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal perfusion catheter insertionAlso: DPC insertionDistal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia. | Procedure or surgery | Provisional distal perfusion catheter insertion group, Routine distal perfusion catheter insertion group |
Primary outcome
Major limb ischemia requiring intervention
Time frame: within 30 days from randomization
Major limb ischemia requiring intervention
10 secondary outcomes
All-cause mortality
Time frame: within 90 days from randomization
Cardiovascular mortality
Time frame: within 90 days from randomization
Successful weaning of mechanical circulatory device
Time frame: within 90 days from randomization
Bleeding
Time frame: within 90 days from randomization
Systemic thromboembolism other than stroke during MCS
Time frame: within 90 days from randomization
Cerebrovascular accidents
Time frame: within 90 days from randomization
Rates of renal replacement therapy during index hospitalization
Time frame: within 30 days from randomization
Duration of MCS during index hospitalization
Time frame: within 30 days from randomization
Duration of hospital stay during index hospitalization
Time frame: within 30 days from randomization
Duration of mechanical ventilation during index hospitalization
Time frame: within 30 days from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong Hoon Yang, MD, PhD principal investigator
Samsung Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal perfusion catheter insertion in people with Cardiogenic Shock and Acute Myocardial Infarction of Inferior Wall, run by Samsung Medical Center at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo Myung Lee, MD, MPH, PhD (82234102575, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major limb ischemia requiring intervention (time frame: within 30 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.