Complex Coronary Artery DiseaseNCT07202754
Procedural Complications and Long-Term Mortality in Complex Coronary Interventions
An observational study of Complex Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The relative risks for different non-fatal intraprocedural complications during complex percutaneous coronary intervention (PCI) on subsequent mortality have not been described. This study aimed to assess the association between non-fatal intraprocedural complications and late mortality after complex coronary PCI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complex Coronary Artery Disease
- How many people
- 20,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2026to 7 Jul 2026
- 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: Complex coronary lesions include chronic total occlusion, osteal epicardial lesions, long (diffuse) coronary disease, severe calcific lesions, true bifurcation disease, left main coronary lesion, lesions with severe thrombus, and in-stent restenosis.
Who may be able to join
- Patients with complex coronary disease
- Aged 18-85 years
Who cannot join
- Patients diagnosed with cardiogenic shock
- Coronary lesions with non-complex features
- Percutaneous coronary intervention with a bare metal stent
- Patient life expectancy <1 year
- Known relevant allergies
- Absence of all medical records
- Patients with early discontinuation of dual antiplatelet therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- 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: The Impact of Procedural Complications on Long-Term Mortality in Complex Coronary Interventions: The Multicenter COMPLEX-ANATOLIA Study
The relative risks for different non-fatal intraprocedural complications during complex percutaneous coronary intervention (PCI) on subsequent mortality have not been described. This study aimed to assess the association between non-fatal intraprocedural complications and late mortality after complex coronary PCI.
Read the detailed description
Complex coronary lesions include chronic total occlusion, osteal epicardial lesions, long (diffuse) coronary disease, severe calcific lesions, true bifurcation disease, left main coronary lesion, lesions with severe thrombus, and in-stent restenosis. Non-fatal intraprocedural complications included abrupt occlusion, worsening of thrombolysis in myocardial infarction (TIMI) flow grade (TIMI < 3), major dissection (greater than type B), occurrence of thrombus formation, perforation of the main vessel or side branch, malignant arrhythmias, stroke/transient ischemic attack, and non-coronary major bleeding.
- Conditions
- Complex Coronary Artery Disease
- Keywords
- Complications, death, major adverse cardiac events, target vessel revascularization
- Medical subject headings
- Death, Cardiovascular Diseases
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 |
|---|---|---|
| Group 1 | Non-fatal complications (+) | |
| Group 2 | Non-fatal complications (-) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All cause death
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start13 May 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Coronary Artery DiseaseStudies 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
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul Training and Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Bagcilar Training and Research Hospital, Ankara Etlik City Hospital, Ankara Bilkent Sehir Hastanesi, Bursa City Hospital, Ege University, Kocaeli University, Trakya University, Van Training and Research Hospital, Cigli Regional Training Hospital, Istanbul University - Cerrahpasa, University of Yalova, Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, Ahmet Guner, Istanbul Mehmet Akif Ersoy Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202754
- Sponsor's protocol ID
- 2025.04-35
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- The Impact of Procedural Complications on Long-Term Mortality in Complex Coronary Interventions: The Multicenter COMPLEX-ANATOLIA Study
- ClinicalTrials.gov ID
- NCT07202754
- Acronym / sponsor ID
- 2025.04-35
- Conditions
- Complex Coronary Artery Disease
- Keywords
- Complications, death, major adverse cardiac events, target vessel revascularization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Collaborators
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul Training and Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Bagcilar Training and Research Hospital, Ankara Etlik City Hospital, Ankara Bilkent Sehir Hastanesi, Bursa City Hospital, Ege University, Kocaeli University, Trakya University, Van Training and Research Hospital, Cigli Regional Training Hospital, Istanbul University - Cerrahpasa, University of Yalova, Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- 13 May 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
The relative risks for different non-fatal intraprocedural complications during complex percutaneous coronary intervention (PCI) on subsequent mortality have not been described. This study aimed to assess the association between non-fatal intraprocedural complications and late mortality after complex coronary PCI.
Detailed description
Complex coronary lesions include chronic total occlusion, osteal epicardial lesions, long (diffuse) coronary disease, severe calcific lesions, true bifurcation disease, left main coronary lesion, lesions with severe thrombus, and in-stent restenosis. Non-fatal intraprocedural complications included abrupt occlusion, worsening of thrombolysis in myocardial infarction (TIMI) flow grade (TIMI < 3), major dissection (greater than type B), occurrence of thrombus formation, perforation of the main vessel or side branch, malignant arrhythmias, stroke/transient ischemic attack, and non-coronary major bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Non-fatal complications (+) |
| Group 2 | – | –Non-fatal complications (-) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Complex coronary lesions include chronic total occlusion, osteal epicardial lesions, long (diffuse) coronary disease, severe calcific lesions, true bifurcation disease, left main coronary lesion, lesions with severe thrombus, and in-stent restenosis.
Key inclusion criteria (2 listed)
- Patients with complex coronary disease
- Aged 18-85 years
Key exclusion criteria (7 listed)
- Patients diagnosed with cardiogenic shock
- Coronary lesions with non-complex features
- Percutaneous coronary intervention with a bare metal stent
- Patient life expectancy <1 year
- Known relevant allergies
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
Death
Time frame: up to 60 months
All cause death
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.
İstanbul Mehmet Akif Ersoy Thoracic And Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site 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 7 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 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: up to 60 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.