NCT07596706

Brief Summary

Coronary artery disease is a leading cause of mortality and morbidity globally. The left coronary artery system is critically important due to its supply of a large area of myocardium. Ostia lesions of left anterior descending artery \[LAD\] and circumflex artery \[CX\]) present technical challenges during percutaneous coronary intervention (PCI) and are considered high-risk lesions due to their anatomical location, relationship with the left main coronary artery bifurcation. Two main approaches exist for treating these lesions: accurate ostial stenting and crossover stenting extending from the left main coronary artery to the relevant branch. Accurate ostial stenting aims to avoid unnecessary stenting of the left main coronary artery, while crossover stenting is more advantageous in terms of ensuring complete coverage of the ostial region. However, the crossover approach may have disadvantages such as larger stent implantation and potential side branch involvement. The current literature does not clearly define the clinical superiority of these two strategies. While various studies have shown no significant difference in mortality, myocardial infarction, and target lesion revascularization, the results are heterogeneous, and a definitive consensus has not been reached. The majority of current data are based on retrospective or observational studies. Therefore, well-designed prospective studies comparing crossover stenting and accurate ostial stenting strategies in the ostial left-sided coronary artery (LAD and CX) lesions are needed. This planned study aims to contribute to this gap in the literature by comparing the clinical outcomes of the two approaches.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jun 2027

Study Start

First participant enrolled

May 12, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Coronary Bifurcation LesionLeft Main Coronary Artery StenosisCoronary Artery Disease (CAD)

Keywords

Ostial LesionLeft anterior descending arteryLeft circumflex arteryCrossover stentingAccurate Ostial Stenting

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac event

    Combination of cardiac death, target vessel myocardial infarction, or target lesion revascularization

    12 months

Study Arms (2)

Accurate Ostial Stenting

Crossover Stenting

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medina 0.0.1 and 0.1.0 left main bifurcation disease

You may qualify if:

  • Ostial left anterior descending artery or left circumflex artery disease
  • Coronary intervention with second or third generation drug-eluting stent

You may not qualify if:

  • Severe left main disease (≥30%, intravascular ultrasound plaque burden \>50%)
  • History of coronary bypass grafting
  • Cardiogenic shock
  • Left main diameter greater than stent expansion capacity (for crossover group)
  • In-stent restenosis
  • End-stage liver or kidney disease (cirrhosis, hemodialysis-dependent chronic kidney disease),
  • Coronary intervention with bare-metal stent
  • Early discontinuation or inappropriate use of DAPT treatment
  • Patients lost to follow-up
  • Patient life expectancy \<1 year (such as cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Hospital

Istanbul, Please Select, 33484, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)