Clinical trial NCT06327659: Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden
Official title: Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Patients With Heavy Thrombus Burden Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: STEMI - ST Elevation Myocardial Infarction
Thrombosis Cardiac
Keywords: STEMI
heavy thrombus burden
manual thrombectomy
50 mL syringe
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Acute ST-segment elevation myocardial infarction (STEMI) poses a major hazard to human life and health due to its high morbidity and deaths. The frequency of STEMI is increasing. Although dual antiplatelet treatment (DAPT) and primary percutaneous coronary intervention (PPCI) have enhanced survival in STEMI suffers during the last 20 years. Complications after myocardial infarction continue to be a major contributor to high mortality and disability.

Treatment focuses on minimizing infarct size by reopening the occluded artery and restoring myocardial perfusion While PPCI is an established treatment option and can reliably re-establish flow, it can also cause distal embolization, resulting in persistent microvascular obstruction and poor myocardial perfusion. Poor myocardial perfusion after PCI is associated with worse left ventricular functional recovery and increased long-term mortality. By removing thrombotic material, aspiration thrombectomy before PCI may reduce the risk of distal embolization and improve myocardial perfusion. A meta-analysis of large randomized trials comparing aspiration thrombectomy and PCI alone found that routine manual aspiration thrombectomy did not improve clinical outcomes. However, in the high thrombus burden subgroup, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack.

For select cardiac populations, particularly those with high thrombus burden, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: TIMI flow grade after PCI
timeFrame: During procedure
measure: MBG after PCI
timeFrame: During procedure
Secondary outcomes:
measure: Composite rate of occurrence of MACE
timeFrame: 30 days after PCI
measure: Rate of cardiovascular death
timeFrame: 30 days after PCI
measure: Rate of recurrent myocardial infarction
timeFrame: 30 days after PCI
measure: Rate of stroke
timeFrame: 30 days after PCI
measure: Rate of cardiogenic shock
timeFrame: 30 days after PCI
measure: Rate of NYHA IV heart failure
timeFrame: 30 days after PCI
Other outcomes:
Locations:
city: Badr
country: Egypt
facility: Badr University Hospital
state: Cairo
Study officials:
affiliation: Helwan University
name: Arafa Gomaa, MD
role: STUDY_DIRECTOR
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