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

NCT06327659 | Not Yet Recruiting Phase 3

• 1 other identifier: Thrombectomy by 50 ml syringe
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Thrombosis Cardiac

Keywords

STEMI; heavy thrombus burden; manual thrombectomy; 50 mL syringe

Outcome Measures

Primary Outcomes (2)

• TIMI flow grade after PCI

  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.

  During procedure

• MBG after PCI

  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.

  During procedure

Secondary Outcomes (6)

• Composite rate of occurrence of MACE

  30 days after PCI

• Rate of cardiovascular death

  30 days after PCI

• Rate of recurrent myocardial infarction

  30 days after PCI

• Rate of stroke

  30 days after PCI

• Rate of cardiogenic shock

  30 days after PCI

Study Arms (2)

Group I

ACTIVE COMPARATOR

Device: 30 mL syringe manual thrombectomy catheter

Group II

EXPERIMENTAL

Device: 50 mL syringe manual thrombectomy catheter

Interventions

30 mL syringe manual thrombectomy catheter DEVICE

30 mL syringe manual thrombectomy catheter

Group I

50 mL syringe manual thrombectomy catheter DEVICE

50 mL syringe manual thrombectomy catheter

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Badr University Hospital

Badr, Cairo Governorate, Egypt

Location

Related Publications (14)

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  PMID: 23247304 BACKGROUND

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  PMID: 12090749 BACKGROUND

• Mathews SJ, Parikh SA, Wu W, Metzger DC, Chambers JW, Ghali MGH, Sumners MJ, Kolski BC, Pinto DS, Dohad S. Sustained Mechanical Aspiration Thrombectomy for High Thrombus Burden Coronary Vessel Occlusion: The Multicenter CHEETAH Study. Circ Cardiovasc Interv. 2023 Feb;16(2):e012433. doi: 10.1161/CIRCINTERVENTIONS.122.012433. Epub 2023 Feb 21.

  PMID: 36802804 BACKGROUND

• Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.

  PMID: 30261959 BACKGROUND

• Kobkitsuksakul C, Jaroenngarmsamer T. Comparison of vacuum pressure syringe aspiration technique with penumbra aspiration thrombectomy system: an in vitro study. Hong Kong J Radiol 2021; 24:47-

  BACKGROUND

• Weinsaft JW, Kim J, Medicherla CB, Ma CL, Codella NC, Kukar N, Alaref S, Kim RJ, Devereux RB. Echocardiographic Algorithm for Post-Myocardial Infarction LV Thrombus: A Gatekeeper for Thrombus Evaluation by Delayed Enhancement CMR. JACC Cardiovasc Imaging. 2016 May;9(5):505-15. doi: 10.1016/j.jcmg.2015.06.017. Epub 2015 Oct 14.

  PMID: 26476503 BACKGROUND

• Lashin H, Olusanya O, Smith A, Bhattacharyya S. Left Ventricular Ejection Fraction Correlation With Stroke Volume as Estimated by Doppler Echocardiography in Cardiogenic Shock: A Retrospective Observational Study. J Cardiothorac Vasc Anesth. 2022 Sep;36(9):3511-3516. doi: 10.1053/j.jvca.2022.05.009. Epub 2022 May 10.

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  PMID: 34362221 BACKGROUND

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  PMID: 35532897 BACKGROUND

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  PMID: 10637197 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Arafa Gomaa, MD

  Helwan University

  STUDY DIRECTOR

Central Study Contacts

Arafa Gomaa, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology consultant

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)