Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main

NCT05933473 | Unknown

• 1 other identifier: Coronary interventions
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective interventional study evaluating clinical and procedural outcomes of patients with ostial left anterior descending artery lesion PCI alone or crossover with left main artery

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of the clinical outcomes using different techniques in ostial LAD

  Evaluate the clinical outcomes in patients undergoing PCI for ostial LAD lesions The primary end points are: -Target vessel related myocardial infarction occuring within 48 hours defined by absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus 1 (or more) of the following criteria: * Flow-limiting angiographic complications. * New "substantial" loss of myocardium on imaging.

  6 months

Secondary Outcomes (3)

• Predictors of PCI success

  6 months

• Predictors of PCI success

  6 months

• Predictors of ostial LAD PCI success

  6 months

Study Arms (2)

LM-LAD (Crossover stenting (CO))

ACTIVE COMPARATOR

Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed.

Procedure: Percutaneous coronary intervention

ostial LAD (Ostial stenting(OS))

ACTIVE COMPARATOR

Ostial stenting of the LAD (OS) with no cross-over back to the LM.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

percutaneous intervention to oseal LAD with or without LM stenting

LM-LAD (Crossover stenting (CO)); ostial LAD (Ostial stenting(OS))

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Significant ostial LAD \>50% stenosis within 5mm from ostium
• Either CCS (ongoing symptoms despite medical therapy) or ACS patients.
• De-novo lesions.

You may not qualify if:

• Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial LCX greater than 50%).
• Patients with protected LM.
• In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 BACKGROUND

• Rigatelli G, Zuin M, Baracca E, Galasso P, Carraro M, Mazza A, Lanza D, Roncon L, Daggubati R. Long-Term Clinical Outcomes of Isolated Ostial Left Anterior Descending Disease Treatment: Ostial Stenting Versus Left Main Cross-Over Stenting. Cardiovasc Revasc Med. 2019 Dec;20(12):1058-1062. doi: 10.1016/j.carrev.2019.01.030. Epub 2019 Jan 31.

  PMID: 30797760 BACKGROUND

• Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol. 1993 Dec;22(7):2033-54. No abstract available.

  PMID: 8245363 BACKGROUND

• Frangos C, Noble S, Piazza N, Asgar A, Fortier A, Ly QH, Bonan R. Impact of bifurcation lesions on angiographic characteristics and procedural success in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Arch Cardiovasc Dis. 2011 Apr;104(4):234-41. doi: 10.1016/j.acvd.2011.02.001. Epub 2011 Apr 19.

  PMID: 21624790 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mohamed AN AbdEl-Reheem, MSC

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AN AbdEl-Reheem, MSC

CONTACT

01119535430; m.naserdrea3@aun.edu.eg

Aly M Tohamy, MD

CONTACT

01006258877; ali.tohamy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: July 6, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share