Coronary Bifurcation LesionNCT07596706
Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
An observational study of Coronary Bifurcation Lesion and Coronary Artery Disease (CAD), run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Bifurcation Lesion, Coronary Artery Disease (CAD), Left Main Coronary Artery Stenosis
- How many people
- 1,000 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 May 2026to 15 Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medina 0.0.1 and 0.1.0 left main bifurcation disease
Who may be able to join
- Ostial left anterior descending artery or left circumflex artery disease
- Coronary intervention with second or third generation drug-eluting stent
Who cannot join
- 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),
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 1 recruiting
- Active, not recruiting
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Hospital
Istanbul, Please Select, 33484
- Recruiting
İstanbul Mehmet Akif Ersoy Thoracic And Cardiovascular Surgery Training and Research Hospital
Istanbul, 33484
Ahmet Güner, 05056533335, ahmetguner488@gmail.com
About this study
Official title: Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions: the Multicenter OSTIAL-ANATOLIA Study
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.
Read the detailed description
There are significant conceptual differences between accurate ostial stenting and crossover stenting strategies extending from the left main coronary artery to the target vessel. The isolated approach aims to avoid unnecessary left main coronary artery stenting, while the crossover technique aims to minimize the risk of residual stenosis by ensuring complete coverage of the ostial segment. However, the current literature presents inconsistent and heterogeneous results regarding the clinical superiority of these two approaches. The current evidence is based on retrospective analyses and observational records, and the lack of prospective and methodologically robust comparative studies is noteworthy. In this context, a prospective evaluation of these two strategies is critical not only for comparing clinical outcomes but also for standardizing the interventional approach. In particular, a systematic comparison based on clinically significant endpoints such as major adverse cardiovascular events (MACE), target lesion revascularization, and procedural success has the potential to fill the existing knowledge gap. This planned study aims to generate high-level evidence regarding which stenting strategy is superior in the treatment of left coronary artery ostial lesions. The findings are expected to make clinical decision-making processes more rational and evidence-based, and to improve patient prognosis. In this respect, the study has high potential for impact both in clinical practice and in the scientific literature.
This study aims to generate high-level evidence regarding which stenting strategy is superior in the treatment of ostial lesions of the left-sided coronary artery. It compares the 1-year clinical outcomes of patients treated with accurate ostial stenting and those treated with crossover stenting extending from the left main coronary artery to the target vessel.
The study was designed as a multicenter and prospective study between May 2026 and May 2027. Patients meeting the inclusion criteria who had critical ostial lesions of the left anterior descending artery and circumflex artery and underwent revascularization with accurate ostial stenting and crossover stenting extending from the left main coronary artery to the target vessel will be included. Patients will attend follow-up visits at 1 month, 6 months, and 12 months. At each visit, routine examinations will include biochemical parameters, ECG, and, if clinically necessary, ischemia investigation (exercise stress test, myocardial perfusion scintigraphy, coronary CT angiography) in the presence of ischemic symptoms. Control angiography will be performed if clinically necessary (>10% ischemia in scintigraphy, unstable angina pectoris, acute coronary syndrome). The following parameters will be recorded in detail in the study dataset for patients: age, gender, height, weight, Body Mass Index, smoking, diabetes mellitus, chronic renal failure, hypertension, hyperlipidemia, peripheral arterial disease, chronic obstructive pulmonary disease, left ventricular ejection fraction, symptoms, previous coronary intervention, multivessel disease, severe valvular disease, medical treatment parameters, procedural and angiographic parameters, 12-month mortality, myocardial Infarction, ee-intervention, stent thrombosis, and stroke.
- Conditions
- Coronary Bifurcation Lesion, Coronary Artery Disease (CAD), Left Main Coronary Artery Stenosis
- Keywords
- Ostial Lesion, Left anterior descending artery, Left circumflex artery, Crossover stenting, Accurate Ostial Stenting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Accurate Ostial Stenting | Not described | |
| Crossover Stenting | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event
Combination of cardiac death, target vessel myocardial infarction, or target lesion revascularization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start12 May 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Yalova Training and Research Hospital, Mersin City Hospital, Van Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Trakya University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul Training and Research Hospital, Medipol University, Samsun Education and Research Hospital, Kocaeli University, Abant Izzet Baysal University, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Bagcilar Training and Research Hospital, Ankara City Hospital Bilkent, Dicle University, Bursa Yuksek Ihtisas Training and Research Hospital, Haseki Training and Research Hospital, Ahi Evran University Education and Research Hospital, Ankara Etlik City Hospital, Izmir Bakircay University, Istanbul Medipol University Hospital, Kutahya City Hospital, Adiyaman University Research Hospital, Adana City Training and Research Hospital, Kosuyolu Heart Hospital, Ege University, Bursa City Hospital, Bilecik Seyh Edebali Universitesi, Siirt Training and Research Hospital, Hitit University
- Responsible party
- Principal investigator, Ahmet Guner, Istanbul Mehmet Akif Ersoy Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596706
- Sponsor's protocol ID
- 2026.05-62
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions: the Multicenter OSTIAL-ANATOLIA Study
- ClinicalTrials.gov ID
- NCT07596706
- Acronym / sponsor ID
- 2026.05-62
- Conditions
- Coronary Bifurcation Lesion, Coronary Artery Disease (CAD), Left Main Coronary Artery Stenosis
- Keywords
- Ostial Lesion, Left anterior descending artery, Left circumflex artery, Crossover stenting, Accurate Ostial Stenting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Collaborators
- Yalova Training and Research Hospital, Mersin City Hospital, Van Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Trakya University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul Training and Research Hospital, Medipol University, Samsun Education and Research Hospital, Kocaeli University, Abant Izzet Baysal University, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Bagcilar Training and Research Hospital, Ankara City Hospital Bilkent, Dicle University, Bursa Yuksek Ihtisas Training and Research Hospital, Haseki Training and Research Hospital, Ahi Evran University Education and Research Hospital, Ankara Etlik City Hospital, Izmir Bakircay University, Istanbul Medipol University Hospital, Kutahya City Hospital, Adiyaman University Research Hospital, Adana City Training and Research Hospital, Kosuyolu Heart Hospital, Ege University, Bursa City Hospital, Bilecik Seyh Edebali Universitesi, Siirt Training and Research Hospital, Hitit University
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are significant conceptual differences between accurate ostial stenting and crossover stenting strategies extending from the left main coronary artery to the target vessel. The isolated approach aims to avoid unnecessary left main coronary artery stenting, while the crossover technique aims to minimize the risk of residual stenosis by ensuring complete coverage of the ostial segment. However, the current literature presents inconsistent and heterogeneous results regarding the clinical superiority of these two approaches. The current evidence is based on retrospective analyses and observational records, and the lack of prospective and methodologically robust comparative studies is noteworthy. In this context, a prospective evaluation of these two strategies is critical not only for comparing clinical outcomes but also for standardizing the interventional approach. In particular, a systematic comparison based on clinically significant endpoints such as major adverse cardiovascular events (MACE), target lesion revascularization, and procedural success has the potential to fill the existing knowledge gap. This planned study aims to generate high-level evidence regarding which stenting strategy is superior in the treatment of left coronary artery ostial lesions. The findings are expected to make clinical decision-making processes more rational and evidence-based, and to improve patient prognosis. In this respect, the study has high potential for impact both in clinical practice and in the scientific literature.
This study aims to generate high-level evidence regarding which stenting strategy is superior in the treatment of ostial lesions of the left-sided coronary artery. It compares the 1-year clinical outcomes of patients treated with accurate ostial stenting and those treated with crossover stenting extending from the left main coronary artery to the target vessel.
The study was designed as a multicenter and prospective study between May 2026 and May 2027. Patients meeting the inclusion criteria who had critical ostial lesions of the left anterior descending artery and circumflex artery and underwent revascularization with accurate ostial stenting and crossover stenting extending from the left main coronary artery to the target vessel will be included. Patients will attend follow-up visits at 1 month, 6 months, and 12 months. At each visit, routine examinations will include biochemical parameters, ECG, and, if clinically necessary, ischemia investigation (exercise stress test, myocardial perfusion scintigraphy, coronary CT angiography) in the presence of ischemic symptoms. Control angiography will be performed if clinically necessary (>10% ischemia in scintigraphy, unstable angina pectoris, acute coronary syndrome). The following parameters will be recorded in detail in the study dataset for patients: age, gender, height, weight, Body Mass Index, smoking, diabetes mellitus, chronic renal failure, hypertension, hyperlipidemia, peripheral arterial disease, chronic obstructive pulmonary disease, left ventricular ejection fraction, symptoms, previous coronary intervention, multivessel disease, severe valvular disease, medical treatment parameters, procedural and angiographic parameters, 12-month mortality, myocardial Infarction, ee-intervention, stent thrombosis, and stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accurate Ostial Stenting | – | – |
| Crossover Stenting | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medina 0.0.1 and 0.1.0 left main bifurcation disease
Key inclusion criteria (2 listed)
- Ostial left anterior descending artery or left circumflex artery disease
- Coronary intervention with second or third generation drug-eluting stent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac event
Time frame: 12 months
Combination of cardiac death, target vessel myocardial infarction, or target lesion revascularization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bifurcation Lesion and Coronary Artery Disease (CAD), run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Güner, MD (+90212692200, ahmetguner488@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.