Using DK Nano-Culotte Stenting for Complex Heart Lesions
A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting
Istanbul Mehmet Akif Ersoy Educational and Training Hospital · NCT05406284
This study is testing a new stenting technique for patients with complex heart conditions to see if it works better than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital (other gov) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05406284 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with true coronary bifurcation lesions, which are complex heart conditions that can lead to adverse cardiovascular outcomes. It evaluates the effectiveness of double kissing (DK) nano-culotte stenting, a technique that may offer advantages over traditional stenting methods. The study aims to determine the optimal stenting strategy for these lesions, particularly in patients with left main coronary artery disease. By comparing DK mini-culotte stenting to other techniques, the research seeks to improve patient outcomes in coronary artery disease management.
Who should consider this trial
Good fit: Ideal candidates include patients with de novo true bifurcation lesions who meet specific anatomical criteria.
Not a fit: Patients with severe heart conditions, recent surgeries, or those unable to undergo long-term antiplatelet therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better stenting outcomes and reduced complications for patients with complex coronary lesions.
How similar studies have performed: Previous studies have shown promising results with similar stenting techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Istanbul Mehmet Akif Ersoy Training and Research Hospital — Istanbul, Turkey (RECRUITING)
Study contacts
- Study coordinator: Serkan Kahraman, Assoc Prof
- Email: serkankahraman_86@outlook.com
- Phone: +905053825921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, coronary bifurcation lesion, DK nano-culotte stenting