Procedural Complications and Long-Term Mortality in Complex Coronary Interventions

NCT ID: NCT07202754

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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

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Complex Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Non-fatal complications (+)

No interventions assigned to this group

Group 2

Non-fatal complications (-)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with complex coronary disease
* Aged 18-85 years

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

OTHER

Sponsor Role collaborator

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role collaborator

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role collaborator

Ankara Bilkent Sehir Hastanesi

OTHER

Sponsor Role collaborator

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Bursa City Hospital

OTHER_GOV

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role collaborator

Kocaeli University

OTHER

Sponsor Role collaborator

Trakya University

OTHER

Sponsor Role collaborator

Van Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Cigli Regional Training Hospital

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

University of Yalova

OTHER

Sponsor Role collaborator

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmet Guner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2025.04-35

Identifier Type: -

Identifier Source: org_study_id

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