Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction
NCT04912570 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2023-07-14
Summary
Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role STEMI patients with heavy thrombus burden (TB).
The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
Conditions
- Coronary Artery Disease
- Percutaneous Coronary Intervention
- ST Elevation Myocardial Infarction
Interventions
- PROCEDURE
-
Manual Thrombus Aspiration
Manual thrombus aspiration using one of the FDA approved aspirators will be done.
- PROCEDURE
-
Standard PCI
Standard PCI according to the most recent guidelines
Sponsors & Collaborators
-
The Young Investigator Group of Cardiovascular Research
lead NETWORK
Principal Investigators
-
Haitham Badran, MD · Ain Shams University - Egypt
-
Mahmoud H Abdelnabi, MD · University of Alexandria - Egypt
-
Ahmed M El Amrawy, MD · University of Alexandria - Egypt
-
Yasser Sadek, MD · National Heart Institute, Egypt
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2024-07-01
- Completion
- 2024-12-01
Countries
- Egypt
Study Locations
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