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Early and Midterm Outcomes of Intravascular Ultrasound (IVUS) Versus Non-IVUS Guidance in Complex Coronary Chronic Total Occlusion (CTO) Revascularization.

NCT04917432 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-06-08

No results posted yet for this study

Summary

Various CTO percutaneous coronary intervention (PCI) studies defined CTO as as a substantial atherosclerotic blockage with \>3 months duration of TIMI (Thrombolysis in Myocardial Infarction) 0 flow other than via collaterals. Following CTO-PCI, various well-established therapeutic benefits have been extensively acknowledged, such as improved angina frequency score and quality of life score from the Seattle Angina Questionnaire (SAQ). Patients are currently referred for CTO PCI to relieve symptoms, reduce ischemia load, or pursue full revascularization to improve left ventricular ejection fraction (LVEF) CTO-PCI is one of the most difficult procedures in interventional cardiology today. Although IVUS has been demonstrated to improve long-term results during CTO PCI when used for stent optimization, its impact on crossing has received little research. IVUS imaging can aid in the resolution of proximal cap ambiguity by determining the position of the main branch and determining the position of the guidewire during CTO crossing efforts both antegrade and retrograde. For the reverse controlled antegrade and retrograde tracking and dissection (reverse CART) procedure, IVUS can help establish the best balloon size. In addition, imaging guidance can help in balloon and stent sizing, as well as stent expansion and strut apposition.

The function of IVUS in CTO PCI has been a source of contention among the four major CTO schools hybrid algorithms. The importance of IVUS-guided entry in overcoming proximal cap uncertainty was underlined in the Asia Pacific algorithm. Furthermore, IVUS-guided wiring, limited subintimal tracking and re-entry are incorporated in the algorithm as alternatives, but only as last resorts. After performing dual coronary injections, the North American hybrid method evaluates four angiographic characteristics, the first of which is a clear understanding of the proximal cap placement utilising angiography or IVUS. They also explain how IVUS guidance can help with reverse CART by allowing for the proper balloon size selection. When proximal cap ambiguity is found in the Euro CTO club algorithm, antegrade procedures such as IVUS-guided puncture and scratch and go technique are performed. When using a primary retrograde approach, the probability of antegrade passing with IVUS guidance and parallel wiring, as well as the advantage of a shorter guide wire crossing time when employing an antegrade route alone, must be incorporated in the Japanese algorithm.

Conditions

  • Chronic Total Occlusion of Coronary Artery

Interventions

PROCEDURE

intravascular ultrasound (IVUS)

Intravascular imaging using a specialized catheter delivered through intra-arterial approach to reach the coronaries to guide CTO-PCI procedure and optimize the results after wire crossing.

PROCEDURE

Conventional CTO PCI (non-IVUS guided)

Non-IVUS guided CTO PCI for wiring but may be used for results optimization after wire crossing

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-09-30
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917432 on ClinicalTrials.gov