Outcomes of Different Techniques of Aortoostial Coronary Intervention Assessed by Coronary Computed Tomography Angiography

NCT06975930 | Not Yet Recruiting DMC

• 1 other identifier: Aorto-ostial coronary PCI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

coronary interventions

Outcome Measures

Primary Outcomes (1)

• Conventional Angiography vs Floating Wire technique in Aorto-ostial coronary PCI.

  Comparison between Aorto-ostial coronary intervention (PCI) using 2D angiography versus Floating wire technique regarding aorto-ostial stent implantation site within the AOLZ which will be assessed by Coronary Computed Tomography Angiography.

  6 months

Secondary Outcomes (1)

• Short term MACE.

  6 months

Study Arms (2)

conventional group

ACTIVE COMPARATOR

patients who will undergo 2D convnetional angiography Aorto-ostial coronary stenting

Procedure: Percutaneous Coronary Intervention (PCI)

Floating Wire group

ACTIVE COMPARATOR

Patients who will undergo Aorto-ostial coronary stenting with Floating wire technique

Procedure: Percutaneous Coronary Intervention (PCI)

Interventions

Percutaneous Coronary Intervention (PCI) PROCEDURE

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.

Also known as: PCI

Floating Wire group; conventional group

Eligibility Criteria

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

You may qualify if:

• All patients \>18 years old who have Aorto-ostial lesions and undergo Aorto-ostial stenting whether they have ACS or CCS.

You may not qualify if:

• All patients who refused CCTA or refused participation in the study.
• Patients with previous Aorto-ostial stents.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University Heart Hospital

Asyut, Egypt

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

EG (1)