Outcomes of Different Techniques of Aortoostial Coronary Intervention Assessed by Coronary Computed Tomography Angiography
NCT06975930 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-05-16
Summary
Aorto-ostial coronary lesions (AOL) are defined as a stenosis \>50% within 3 mm of the orifice of the right coronary artery (RCA) or left main coronary artery (LMCA).
The prevalence of AOL varies according to the studied population and is more common in the RCA.
Aorto-ostial lesions commonly have a unique three-dimensional funnel-shaped morphology with a variable angle of takeoff of the coronary artery from the aorta.
Percutaneous treatment of AOL is challenging due to a variety of factors which include unfavorable lesion histology, complex 3D anatomy, inability of conventional angiography to reliably delineate the aorto-ostial plane and guide the intervention and unsuitability of current tubular stent designs for this lesion subset.
Coronary computed tomography angiography (CCTA) clearly defines AOL anatomy, its relation to the aortic wall and the degree of plaque calcification.
CCTA is uniquely suited to assess the accuracy of AOL stent implantation. While conventional single wire technique is the most commonly used approach for AOL stenting, An approach uses an accessory free floating guide-wire placed within the aortic sinus to mark the aorto-ostial plane and prevent entry of the catheter into the coronary artery is called floating wire technique \& is being used now.
Aim of work: 1-Comparison between 2D angiography versus Floating wire technique regarding aorto-ostial stent implantation site within the AOLZ assessed by CCTA .
2- Short term outcomes regading MACE in both groups including : myocardial infarction (MI), stroke, all-cause mortality and target vessel revascularisation (TVR).
* Type of the study: This is a randomized prospective cross sectional study
* Duration of the study: Patients will be recruited over a period of 12 months.
* Study Population: The study will include all patients who will undergo aorto-ostial coronary stenting \& patients will be categorized into 2 groups Group A:patients who will undergo 2D convnetional angiography Aorto-ostial stenting.
Group B: Patients who will undergo Aorto-ostial stenting with Floating wire technique.
Patients will undergo CCTA to detect geographic miss within 6 months of stent impalntation.
Both groups will be followed up clinically to detect adverse clinical outcomes such as AMI, recurrent chest pain,….etc.
Methdos:
Optimal AOL stenting requires placement of the entire circumference of the proximal stent edge within the aorto-ostial landing zone (AOLZ), defined as the area along the axis of the coronary artery located within 1 mm of the aorto-ostial plane.
Stent geographic miss may be diagnosed when at least a segment of the circumference of the proximal stent edge is located proximal or distal to the AOLZ.
Accurate AOL stent implantation is crucial. If geographic miss was attributed to the angulated vessel take-off from the aorta preventing precise localisation of the cylindrical stent structure within the constraints of the AOLZ, it is defined as anatomy-dependent.
Geographic miss in which all aspects of the proximal stent edge extended beyond the AOLZ either proximally or distally was attributed to incorrect implantation of the stent and was defined as procedure-dependent.
Conditions
- Coronary Interventions
Interventions
- PROCEDURE
-
Percutaneous Coronary Intervention (PCI)
Patients with Aortoostial coronary lesion undergoing PCI will be blindly randomized into 2 groups Conventional group: patients who will undergo 2D convnetional angiography Aorto-ostial coronary stenting. Floating Wire group: Patients who will undergo Aorto-ostial coronary stenting with Floating wire technique.
Sponsors & Collaborators
-
Assiut University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Egypt
Study Locations
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