NCT06951724

Brief Summary

To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2025Jun 2026

Study Start

First participant enrolled

February 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 23, 2025

Last Update Submit

April 23, 2025

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (1)

  • The rate of TIMI flow grad 3 after PCI

    Defined as the percentage of subjects with TIMI flow graded 3 after PCI.

    Immediately after procedure

Secondary Outcomes (8)

  • TIMI flow after PCI

    Immediately after procedure

  • MBG

    Immediately after procedure

  • TIMI Thrombus Grade

    Immediately after procedure

  • STR(ST-segment resolution) at 90 minutes

    Day 0

  • Thrombus aspiration time and number of aspirations

    Immediately after procedure

  • +3 more secondary outcomes

Study Arms (2)

Test Group

EXPERIMENTAL

Thrombus aspiration therapy using the test device

Device: Aspiration Catheter

Control Group

EXPERIMENTAL

Thrombus aspiration therapy using the control device

Device: Export Advance Aspiration Catheter

Interventions

Aspiration CatheterDEVICE

Thrombus aspiration using Aspiration Catheter

Test Group
Export Advance Aspiration CatheterDEVICE

Thrombus aspiration using Export Advance Aspiration Catheter

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years old (inclusive);
  • Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
  • DSA image showed that the target lesion was in situ coronary artery lesion;
  • Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;

You may not qualify if:

  • previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
  • Comorbid cardiogenic shock;
  • severe renal failure or ongoing dialysis;
  • severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
  • Failure of preoperative thrombolysis requiring remedial PCI;
  • Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
  • Ischemic stroke within 3 months prior to surgery;
  • Known allergy to anticoagulant and antiplatelet agents or contrast media;
  • female subjects who are known to be pregnant or lactating;
  • Participation or planned participation in other clinical studies of drugs or devices;
  • other conditions that the investigator evaluates to be unsuitable for participation in this trial.
  • Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
  • severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
  • the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
  • the presence of severe triple coronary artery lesions requiring revascularization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ge Junpo, Ph.D

CONTACT

021-31587851ge.junbo@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2025

First Posted

April 30, 2025

Study Start

February 20, 2025

Primary Completion

February 20, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)