The Thrombus Aspiration During PCI After Thrombolysis in STEMI

NCT06654453 | Recruiting DMC

• 1 other identifier: KYZ20240204
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether thrombus aspiration combined with percutaneous coronary intervention (PCI) improves clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients with high thrombus burden post-thrombolysis, compared to PCI alone. The study population includes 3500 STEMI patients, confirmed by diagnosis, who are transferred to PCI centers after receiving thrombolysis and have no contraindications to thrombolysis.The main questions it aims to answer are:

1. 1.Does thrombus aspiration reduce 30-day major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, stroke, or heart failure rehospitalization?
2. 2.Can thrombus aspiration improve microcirculation and clinical outcomes for high thrombus burden patients after thrombolysis? Researchers will compare patients randomly assigned to receive thrombus aspiration combined with PCI versus those who receive PCI alone to evaluate the effects on reducing MACE and improving clinical recovery.

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

ST-segment elevation myocardial infarction; Thrombus aspiration; Percutaneous coronary intervention; High thrombus burden; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 30-day Major Adverse Cardiovascular Events (MACE)

  A composite of cardiovascular death, recurrent myocardial infarction, stroke, and rehospitalization for heart failure within 30 days post-intervention.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (5)

• Reperfusion Success

  Within 30 minutes post-PCI (Percutaneous Coronary Intervention)

• Follow-up MACE at 6 Months

  From enrollment to the end of treatment at 6 months

• Follow-up all-cause mortality at 6 Months

  From enrollment to the end of treatment at 6 months

• Follow-up MACE at 12 Months

  From enrollment to the end of treatment at 12 months

• Follow-up all-cause mortality at 12 Months

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Thrombectomy + PCI Arm

EXPERIMENTAL

This group will receive thrombectomy combined with percutaneous coronary intervention.

Procedure: Thrombectomy; Procedure: Percutaneous Coronary Intervention

PCI-only Arm

ACTIVE COMPARATOR

PCI is an established treatment for STEMI, and you are comparing it to the experimental group that receives an additional thrombectomy procedure.

Procedure: Percutaneous Coronary Intervention

Interventions

Thrombectomy PROCEDURE

Manual thrombectomy followed by Percutaneous Coronary Intervention (PCI), a procedure involving mechanical removal of thrombus before stent placement in coronary arteries to restore blood flow in STEM

Thrombectomy + PCI Arm

Percutaneous Coronary Intervention PROCEDURE

Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.

PCI-only Arm; Thrombectomy + PCI Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with STEMI.
• No contraindications for thrombolysis and has received thrombolytic treatment.
• Undergoing coronary angiography within 2 to 24 hours post-thrombolysis.
• Angiographic results confirm TIMI thrombus load ≥ 4 and residual stenosis \> 50%.

You may not qualify if:

• Contraindications for thrombolysis.
• Cardiogenic shock.
• Need for coronary artery bypass grafting.
• Age less than 18 years.
• Life expectancy of less than 6 months.
• Unable to provide informed consent.

Sponsors & Collaborators

• Shenghua Zhou: lead

Study Sites (1)

Department of General Surgery, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011 Hunan, PR China

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Thrombectomy; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Minimally Invasive Surgical Procedures

Central Study Contacts

Shenghua Zhou

CONTACT

073185292012; zhoushenghua@csu.edu.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: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: To access the IPD and supporting information, interested parties should contact the principal investigator or designated study coordinator.

Locations

CN (1)