An interventional study of Percutaneous coronary intervention in Coronary Artery Disease, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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
Aim of the work:
Patients and methods:
1)Patients:
Inclusion criteria:
Exclusion Criteria:
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:
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:
A. Quantitative angiographic measurements:
B. Techniques used:
Basic IVUS Measurement
The following basic measurements may be made with IVUS:
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:
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):
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 72 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Percutaneous coronary intervention
Ostial stenting of the LAD (OS) with no cross-over back to the LM.
Procedure: Percutaneous coronary intervention
percutaneous intervention to oseal LAD with or without LM stenting
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.
Time frame: 6 months
Predictors of PCI success
-Angiographic success in target vessel defined as residual stenosis ≤ 30% and TIMI flow grade 3
Time frame: 6 months
Predictors of PCI success
-Angiographic success in target vessel defined as SB angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3).
Time frame: 6 months
Predictors of ostial LAD PCI success
-Procedural Success by doing successful PCI without in-hospital major clinical complications wihin one week of hospitalizaion
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Assiut University