DK Nano-Culotte Stenting For Coronary Bifurcation Lesion

Launched by ISTANBUL MEHMET AKIF ERSOY EDUCATIONAL AND TRAINING HOSPITAL · Jun 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new stenting technique called DK Nano-Culotte stenting for patients with a specific type of heart condition known as coronary artery disease. In this condition, blockages form in the arteries that supply blood to the heart. The trial focuses on patients with complex blockages at the points where arteries split, known as bifurcation lesions. The aim is to see if this new technique can provide better outcomes compared to existing methods, especially for patients who have certain characteristics, such as having a specific size of arteries involved in the blockage.

To be eligible for this trial, participants must have a new blockage in the arteries that fits certain criteria, like specific sizes of the main and side arteries. However, there are some conditions that would exclude someone from participating, such as having a recent heart attack or severe heart failure, or not being able to take certain medications needed after the procedure. Participants can expect to receive this innovative stenting procedure and will be monitored closely to see how well it works over time. This trial is currently looking for volunteers, and those who qualify will play an important role in helping researchers understand the potential benefits of this new technique.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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