Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting

Coronary Artery Disease Clinical Trial

Official title:

Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04581837
• Other study ID #: 2DSTEBIFURCATION
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: Ahmed A Mekawy, bachelor
• Phone: +201004051049
• Email: ahmed.adel6871[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of possible predictors of occlusion of jailed side branches following main vessel coronary artery stenting and detection of clinical, electrocardiographic and echocardiographic changes following occlusion of jailed side branches postprocedural and at 3 months follow-up.

Description:

Coronary bifurcation lesion (CBL) involves coronary artery stenosis adjacent to and/or including the origin of a significant side branch (SB) 1. Treatment of bifurcation lesions constitute about 15% of coronary interventions and are consequently of major clinical interest 2. Even in the modern era of per-cutaneous coronary intervention(PCI) with stent implantation, treatment of bifurcations is hampered by a higher event rate and requires longer procedure time, more radiation exposure, and higher volumes of contrast material compared with non-bifurcation lesions 3 .

Occlusion of large side branches (SBs) may result in significant adverse clinical events 4. Occlusion of jailed sizable septal and right ventricular (RV) side branches (non-classic bifurcations) is often overlooked following left anterior descending (LAD) and right coronary artery (RCA) main vessel stenting, respectively. Most of the operators decline intervening in these side branches on contrary to classic bifurcations as diagonals and obtuse marginal branches, for example. Whether or not intervening with these occluded jailed side branches have clinical implications or even sub clinical left ventricular (LV) dysfunction was not previously elucidated and warrants studying.

Left ventricular function is an important predictor of outcome in patients with coronary artery disease (CAD). Extensive myocardial ischemia can cause decreased LV contractility and function 5. Conventional echocardiography enables us to identify significant left ventricular dysfunction but not sub-clinical dysfunction [10]. Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deterioration of contractility 6 .

In this study, investigators tried to explore the possible predictors and outcomes following occlusion of jailed side branches after main vessel coronary artery stenting, in both classic and non-classic bifurcations, and whether intervening via various techniques would have clinical benefit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients presenting to cathlab for elective PCI along one year duration

• patients who have significant main vessel lesion subtending large, sizable (=2mm) side branches (Medina 1,0,0 / 1,1,0 / 0,1,0)

Exclusion Criteria:

• acute myocardial infarction

• previous CABG

• LV EF<50%

• baseline SWMA in the territory of the vessel to be stented

• totally occluded main vessel.

• small (<2mm) side branch

• any ostial, mid or distal significant side branch disease at baseline.

• true bifurcation lesions (Medina 1,0,1 / 1,1,1 / 0,1,1) with upfront 2-stent strategy.

• advanced renal impairement

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• 2D-speckle tracking echocardiography
Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deteriorations of contractility. we will take 2D speckle tracking views for LV and RV strain (4ch, 2ch, 3ch, RV modified view).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Mohamed Alsenbsey, Basem Asham, Sanaa Shaker Aly, Samar Sayed Ahmed, A. B. Role of insulin resistance in essential hypertensive patients in Qena Governorate, Egypt. Al-Azhar Assiut Med. J. 16, 99-104 (2018).

Palinggi BP, Firman D. Carina Bifurcation Angle and Side Branch Occlusion in Coronary Bifurcation Lesions Intervention: Angiographic Lesions Characteristic Role in Determining Its Relation. Int J Angiol. 2019 Jun;28(2):137-141. doi: 10.1055/s-0038-1676042. Epub 2018 Nov 29. — View Citation

Tsuchida K, Colombo A, Lefèvre T, Oldroyd KG, Guetta V, Guagliumi G, von Scheidt W, Ruzyllo W, Hamm CW, Bressers M, Stoll HP, Wittebols K, Donohoe DJ, Serruys PW. The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularization Therapies Study part II (ARTS II). Eur Heart J. 2007 Feb;28(4):433-42. Epub 2007 Jan 31. — View Citation

Wang P, Liu Y, Ren L. Evaluation of left ventricular function after percutaneous recanalization of chronic coronary occlusions : The role of two-dimensional speckle tracking echocardiography. Herz. 2019 Apr;44(2):170-174. doi: 10.1007/s00059-017-4663-1. Epub 2018 Jan 16. — View Citation

Yurtdas M, Asoglu R, Özdemir M, Asoglu E. An Upfront Two-Stent Strategy for True Coronary Bifurcation Lesions with A Large Side Branch in Acute Coronary Syndrome: A Two-Year Follow-Up Study. Medicina (Kaunas). 2020 Feb 29;56(3). pii: E102. doi: 10.3390/medicina56030102. — View Citation

Zhang D, Xu B, Yin D, Li Y, He Y, You S, Qiao S, Wu Y, Yan H, Yang Y, Gao R, Dou K. Predictors and Periprocedural Myocardial Injury Rate of Small Side Branches Occlusion in Coronary Bifurcation Intervention. Medicine (Baltimore). 2015 Jun;94(25):e992. doi: 10.1097/MD.0000000000000992. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of changes in sub-clinical LV dysfunction after elective PCI to bifurcation lesions by detecting changes in LV global and regional longitudinal strain by 2D-speckle tracking echocardiography.		post-procedural (immediately after procedure) and at 3-months follow-up
Secondary	Detection of peri-procedural myocardial injury (PMI)		within 3 months