Status:
RECRUITING
DK Nano-Culotte Stenting For Coronary Bifurcation Lesion
Lead Sponsor:
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-90 years
Brief Summary
True coronary bifurcation lesions are still great of interest due to their complex anatomy, uncertainty of optimal stenting strategy and increased adverse cardiovascular outcomes. Provisional stenting...
Eligibility Criteria
Inclusion
- Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
- The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm
Exclusion
- Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
- Patients with a history of coronary artery bypass grafting surgery
- Patients with a chronic total occlusion in the bifurcation area
- Lesions with severe calcification that needs additional intervention such as atherectomy
- Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
- Patients with hematological disorders, malignancy, end stage renal (GFR\<30 ml/min) and hepatic failure
- Patients with active bleeding
- Pregnant women
- Patients with life-expectancy \< 1 year
- Patients treated with small open cell stent platforms
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05406284
Start Date
July 1 2024
End Date
December 30 2025
Last Update
January 14 2025
Active Locations (1)
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1
Istanbul Mehmet Akif Ersoy Training and Research Hospital
Istanbul, Turkey (Türkiye), 34303