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Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with Significant ostial LAD >50% stenosis within 5mm from ostium Either CCS (ongoing symptoms despite medical therapy) or ACS patients. De-novo lesions. Exclusion Criteria: Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial LCX greater than 50%). Patients with protected LM. In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    LM-LAD (Crossover stenting (CO))

    ostial LAD (Ostial stenting(OS))

    Arm Description

    Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed.

    Ostial stenting of the LAD (OS) with no cross-over back to the LM.

    Outcomes

    Primary Outcome Measures

    Evaluation of the clinical outcomes using different techniques in ostial LAD
    Evaluate the clinical outcomes in patients undergoing PCI for ostial LAD lesions The primary end points are: -Target vessel related myocardial infarction occuring within 48 hours defined by absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus 1 (or more) of the following criteria: Flow-limiting angiographic complications. New "substantial" loss of myocardium on imaging.

    Secondary Outcome Measures

    Predictors of PCI success
    -Angiographic success in target vessel defined as residual stenosis ≤ 30% and TIMI flow grade 3
    Predictors of PCI success
    -Angiographic success in target vessel defined as SB angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3).
    Predictors of ostial LAD PCI success
    -Procedural Success by doing successful PCI without in-hospital major clinical complications wihin one week of hospitalizaion

    Full Information

    First Posted
    April 7, 2023
    Last Updated
    June 26, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05933473
    Brief Title
    Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main
    Official Title
    Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Prospective interventional study evaluating clinical and procedural outcomes of patients with ostial left anterior descending artery lesion PCI alone or crossover with left main artery
    Detailed Description
    Aim of the work: Evaluate the clinical and procedural outcomes in patients undergoing percutaneous intervention (PCI) for ostial left anterior descending (LAD) lesions while comparing the outcomes between those treated with a stent crossing over (CO) to the left main (LM) versus ostial stenting (OS) alone. Define predictors of success in Ostial LAD lesion PCI. Patients and methods: 1)Patients: Inclusion criteria: Patients with Significant ostial LAD >50% stenosis within 5mm from ostium Either chronic coronary syndrome (CCS) (ongoing symptoms despite medical therapy) or acute coronary syndrome (ACS) patients. De-novo lesions. Exclusion Criteria: Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial left circumflex (LCX) greater than 50%). Patients with protected LM. In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure. Methods: It is prospective cohort study on patients in Assiut university heart hospital catheterization lab. with ostial LAD lesion (median, 0.1.0) that will include baseline demographic, clinical, and angiographic data. All patients will be thoroughly informed about the procedure's possible risks and benefits, as well as alternative therapeutic choices prior to the intervention, and obtained signed consent from all participants. In all cases, percutaneous coronary interventions and stenting will be performed according to standard techniques either trans-radial or transfemoral approach. All patients pre-treated with dual antiplatelet therapy, including aspirin and loading dose of either clopidogrel or ticagrelor. Unfractionated heparin will be given to all patients during the procedure with a target activated clotting time of >250 seconds. Two main strategies for treating ostial LAD lesions will be used and analyzed in this study: Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed. Ostial stenting of the LAD (OS) with no crossover back to the LM. The choice of the technique and the use of intravascular imaging (IVUS) depends on the discretion of the treating interventional cardiologist. Patients included in our study will be subjected to: Detailed History. General and complete cardiac examination. 12-Leads ECG. Detailed Echocardiography. \ 5)Coronary angiography findings including: A. Quantitative angiographic measurements: Reference diameter (mm). Diameter stenosis (%). Lesion length and distance from LAD ostium(mm). Medina classification. Bifurcation angle. B. Techniques used: Ostial LAD stenting. Crossover with LM. C. IVUS or angiography guided PCI. Basic IVUS Measurement The following basic measurements may be made with IVUS: Minimum lumen diameter (MLD): the shortest diameter via lumen's center. Minimum lumen area (MLA): the smallest area via the lumen's center. Stenosis area: (reference lumen area - stenosis lumen area)/reference lumen area. Plaque burden: (EEM area - lumen area) / EEM area . D. Contrast volume (ml) E. Fluoroscopy time (min.) Data will be gathered during hospital admission and follow-up. In-hospital mortality and morbidity will be documented. Follow up: During the hospital admission: Both techniques used by our operators in these cases will be overviewed and evaluated as regarding: Angiographic success in target vessel defined as (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch (SB) angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3). Procedural Success A successful PCI should achieve angiographic success without in-hospital major clinical complications (e.g., cardiac death, target vessel related MI, emergency coronary artery bypass surgery) during hospitalization Clinical Success in the short term, a clinically successful PCI includes anatomic and procedural success with relief of signs and/or symptoms of myocardial ischemia after the patient recovers from the procedure. Information about the in-hospital outcome will be obtained from an electronic clinical database for patients maintained at our institution and by review of hospital records for those discharged to referring hospitals. Short term follow up (after 6 months): Per our institutional protocol, clinical follow-up will be performed by physicians in outpatient clinic after 4 months. Control coronary angiography will be scheduled at 6 months to all cases. Information on the occurrence of cardiac death, target vessel related myocardial infarction or repeated revascularization during period of follow-up will be collected by consulting our institutional electronic database and by contacting referring physicians and institutions and all living patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LM-LAD (Crossover stenting (CO))
    Arm Type
    Active Comparator
    Arm Description
    Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed.
    Arm Title
    ostial LAD (Ostial stenting(OS))
    Arm Type
    Active Comparator
    Arm Description
    Ostial stenting of the LAD (OS) with no cross-over back to the LM.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous coronary intervention
    Intervention Description
    percutaneous intervention to oseal LAD with or without LM stenting
    Primary Outcome Measure Information:
    Title
    Evaluation of the clinical outcomes using different techniques in ostial LAD
    Description
    Evaluate the clinical outcomes in patients undergoing PCI for ostial LAD lesions The primary end points are: -Target vessel related myocardial infarction occuring within 48 hours defined by absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus 1 (or more) of the following criteria: Flow-limiting angiographic complications. New "substantial" loss of myocardium on imaging.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Predictors of PCI success
    Description
    -Angiographic success in target vessel defined as residual stenosis ≤ 30% and TIMI flow grade 3
    Time Frame
    6 months
    Title
    Predictors of PCI success
    Description
    -Angiographic success in target vessel defined as SB angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3).
    Time Frame
    6 months
    Title
    Predictors of ostial LAD PCI success
    Description
    -Procedural Success by doing successful PCI without in-hospital major clinical complications wihin one week of hospitalizaion
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with Significant ostial LAD >50% stenosis within 5mm from ostium Either CCS (ongoing symptoms despite medical therapy) or ACS patients. De-novo lesions. Exclusion Criteria: Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial LCX greater than 50%). Patients with protected LM. In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed AN AbdEl-Reheem, MSC
    Phone
    01119535430
    Email
    m.naserdrea3@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aly M Tohamy, MD
    Phone
    01006258877
    Email
    ali.tohamy@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed AN AbdEl-Reheem, MSC
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29891620
    Citation
    Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
    Results Reference
    background
    PubMed Identifier
    30797760
    Citation
    Rigatelli G, Zuin M, Baracca E, Galasso P, Carraro M, Mazza A, Lanza D, Roncon L, Daggubati R. Long-Term Clinical Outcomes of Isolated Ostial Left Anterior Descending Disease Treatment: Ostial Stenting Versus Left Main Cross-Over Stenting. Cardiovasc Revasc Med. 2019 Dec;20(12):1058-1062. doi: 10.1016/j.carrev.2019.01.030. Epub 2019 Jan 31.
    Results Reference
    background
    PubMed Identifier
    8245363
    Citation
    Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol. 1993 Dec;22(7):2033-54. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21624790
    Citation
    Frangos C, Noble S, Piazza N, Asgar A, Fortier A, Ly QH, Bonan R. Impact of bifurcation lesions on angiographic characteristics and procedural success in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Arch Cardiovasc Dis. 2011 Apr;104(4):234-41. doi: 10.1016/j.acvd.2011.02.001. Epub 2011 Apr 19.
    Results Reference
    background

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    Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main

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