BridgeMD
New treatment option for ST-segment Elevation Myocardial Infarction (STEMI)
Official title Coronary Aspiration Catheter Clinical Trial
ClinicalTrials.gov ID: NCT06951724
What this study is testing
- What it's testing
- To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- \- General 1. 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...
- Voluntary participation and signed written informed consent. Imaging 4. 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 likely can't join if
- \- 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;
See the full eligibility criteria
- \- General 1. 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...
- Voluntary participation and signed written informed consent. Imaging 4. 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;
- \- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.