NCT07482865

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Oct 2030

First Submitted

Initial submission to the registry

March 15, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

March 15, 2026

Last Update Submit

March 18, 2026

Conditions

Cardiogenic ShockCongestive Heart FailureAcute Myocardial Infarction of Inferior WallMyocarditisAcute Limb Ischemia

Keywords

Cardiogenic ShockDistal perfusion catherterAcute Myocardial InfarctionCongestive Heart FailureLimb ischemia

Outcome Measures

Primary Outcomes (1)

  • Major limb ischemia requiring intervention

    Major limb ischemia requiring intervention

    within 30 days from randomization

Secondary Outcomes (10)

  • All-cause mortality

    within 90 days from randomization

  • Cardiovascular mortality

    within 90 days from randomization

  • Successful weaning of mechanical circulatory device

    within 90 days from randomization

  • Bleeding

    within 90 days from randomization

  • Systemic thromboembolism other than stroke during MCS

    within 90 days from randomization

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Distal perfusion catheter insertion

Interventions

Distal perfusion catheter insertionPROCEDURE

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

Also known as: DPC insertion
Provisional distal perfusion catheter insertion groupRoutine distal perfusion catheter insertion group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Samsung Medical Center Changwon Hospital

Changwon, South Korea

Location

Kwandong University Intl. ST. Mary's Hospital

Incheon, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Eunpyeong St. Mary's Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Shock, CardiogenicInferior Wall Myocardial InfarctionHeart FailureMyocarditis

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockCardiomyopathies

Study Officials

  • Jeong Hoon Yang, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

82234102575drone80@hanmail.net

Jeong Hoon Yang, MD, PhD

CONTACT

82234102575jhysmc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Clinical events will be independently adjudicated by Clinical Event Adjudication Committee whose members are blinded to the assignmet groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

October 31, 2030

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

After publication of primary report, IPD will be shared upon reasonable requests after discussion in the Executive Committee.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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).

Locations

KR(6)