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Recruiting NCT06951724

Coronary Aspiration Catheter Clinical Trial

No phase Interventional ST-segment Elevation Myocardial Infarction (STEMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspiration Catheter, Export Advance Aspiration Catheter.
Who it may be relevant to
Registry conditions: ST-segment Elevation Myocardial Infarction (STEMI). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)

Overview

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

Interventions

  • Device Aspiration Catheter
    Thrombus aspiration using Aspiration Catheter
  • Device Export Advance Aspiration Catheter
    Thrombus aspiration using Export Advance Aspiration Catheter

Primary outcome measures

  • The rate of TIMI flow grad 3 after PCI [Time frame: Immediately after procedure]
Secondary outcome measures (8)
  • TIMI flow after PCI [Time frame: Immediately after procedure]
  • MBG [Time frame: Immediately after procedure]
  • TIMI Thrombus Grade [Time frame: Immediately after procedure]
  • STR(ST-segment resolution) at 90 minutes [Time frame: Day 0]
  • Thrombus aspiration time and number of aspirations [Time frame: Immediately after procedure]
  • Device technical success rate [Time frame: Immediately after procedure]
  • MACE [Time frame: 30-day follow-up after procedure]
  • AE and SAE [Time frame: 30-day follow-up after procedure]

Eligibility criteria

Inclusion criteria

\- General inclusion criteria

  • 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);
  • Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
  • 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;

Exclusion criteria

\- General exclusion criteria

  • 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.

Imaging exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06951724 · D23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗