Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Patients With Heavy Thrombus Burden Undergoing Primary Percutaneous Coronary Intervention
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Helwan University
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- MBG after PCI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group I
Intervention: 30 mL syringe manual thrombectomy catheter (Device)
Group II
Intervention: 50 mL syringe manual thrombectomy catheter (Device)
Outcomes
Primary Outcomes
MBG after PCI
Time Frame: During procedure
Myocardial blush grade (MBG): * Grade 0: No myocardial blush or contrast density. * Grade 1: Minimal myocardial blush or contrast density. * Grade 2: Moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery. * Grade 3: Normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery.
TIMI flow grade after PCI
Time Frame: During procedure
Thrombolysis in Myocardial Infarction (TIMI) flow grades: * Grade 0: There is no antegrade flow or perfusion beyond the blockage. * Grade 1 indicates that the contrast material was able to flow through the blockage during the cineangiographic recording series without totally obstructing the coronary bed distal to the obstruction. * Grade 2: The coronary artery distal to the occlusion is opacified by the contrast material at a much slower pace than in regions unaffected by the prior closure. * Grade 3: indicates contrast material is cleared from the affected bed at the same rate as it is cleared from an unaffected bed in the same or opposite artery.
Secondary Outcomes
- Composite rate of occurrence of MACE(30 days after PCI)
- Rate of recurrent myocardial infarction(30 days after PCI)
- Rate of cardiogenic shock(30 days after PCI)
- Rate of cardiovascular death(30 days after PCI)
- Rate of stroke(30 days after PCI)
- Rate of NYHA IV heart failure(30 days after PCI)
Investigators
Arafa Gomaa
Cardiology consultant
Helwan University