NCT05406284Completed
DK Nano-Culotte Stenting For Coronary Bifurcation Lesion
A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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 is recommended in patients with non-complex coronary lesions while 2-stent strategies should be considered in complex coronary bifurcation lesions. However, optimal 2-stent strategy is still controversial. Double kissing (DK) crush stenting is the prominent technique in true bifurcation lesion, especially in patients with left main coronary artery disease. DK mini-culotte stenting, increasing use in clinical practice, has become popular over DK crush stenting. It was demonstrated in a bench test that stent malapposition was lower in the DK mini-culotte stenting compared to the DK crush technique. Thus, DK mini-culotte stenting may be preferred over DK crush stenting in complex true coronary bifurcation lesion. On the other hand, it was demonstrated in previous studies, less than minimal protrusion (generally called as nano protrusion) had better clinical outcomes. Kawasaki et al was first demonstrated the minimal (nano) protrusion of culotte stenting technique. Then, Toth et al revealed a novel modified culotte stenting technique named single string culotte. There was no major adverse cardiac events (MACE) in patients underwent single string stenting technique with a median follow-up period of 6±4 months. Unsurprisingly there was no MACE occurred in patients who underwent Szabo 2-stent technique. In the light of foregoing data, the least possible amount of protrusion is known to have the best results. In addition to this, double kissing balloon dilatation with culotte stenting technique seems to have better results than other stenting techniques. In our study, we aimed to evaluate the angiographic and clinical results of a novel DK Nano-Culotte stenting in coronary bifurcation lesion.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 43 (actual)
- First submitted
- 1 Jun 2022
- Start date
- 1 Jul 2024
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05406284
What you commit to
- Study type: Observational
- Participants enrolled: 43
- From 1 Jul 2024 to the primary completion date, 15 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
- Patients treated with small open cell stent platforms
Other illness
- 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 active bleeding
Lab values
- Patients with hematological disorders, malignancy, end stage renal (GFR\<30 ml/min) and hepatic failure
Other
- Patients with a chronic total occlusion in the bifurcation area
- Lesions with severe calcification that needs additional intervention such as atherectomy
- Pregnant women
- Patients with life-expectancy \< 1 year
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istanbul Mehmet Akif Ersoy Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.