Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04917432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-06-08
First Post:
2021-05-27
Brief Title:
Early and Midterm Outcomes of Intravascular Ultrasound IVUS Versus Non-IVUS Guidance in Complex Coronary Chronic Total Occlusion CTO Revascularization
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Early and Midterm Outcomes of Intravascular Ultrasound IVUS Versus Non-IVUS Guidance in Complex Coronary Chronic Total Occlusion CTO Revascularization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None