UnknownPhase 3

Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden

Egypt88 participantsStarted 2024-04-01

Plain-language summary

In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with STEMI within 12-24 h of symptom onset in native coronary vessel with heavy thrombus burden (Thrombolysis in Myocardial Infarction \[TIMI\] thrombus grade 4 or 5 on angiography after the guidewire crossed the target lesion) Exclusion Criteria: * Very delayed STEMI presentation. * STEMI with low thrombus burden. * STEMI with cardiogenic shock. * Failed recanalization of culprit vessel. * Complex coronary anatomy candidates for coronary artery bypass graft.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TIMI flow grade after PCI

Timeframe: During procedure

MBG after PCI

Timeframe: During procedure

Trial details

NCT IDNCT06327659

SponsorHelwan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

Contact for this trial

Arafa Gomaa, MD

+201159541000 arafa.gomaa@med.helwan.edu.eg

View on ClinicalTrials.gov More STEMI - ST Elevation Myocardial Infarction trials