Clinical trial NCT05406284: DK Nano-Culotte Stenting For Coronary Bifurcation Lesion
Official title: A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: coronary bifurcation lesion
DK nano-culotte stenting
Lead sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stable or unstable angina pectoris or patients with non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention and performing DK nano culotte stunting technique

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 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.


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

Primary outcomes:
measure: MACE (major adverse cardiovascular events)
timeFrame: 6 months
Secondary outcomes:
measure: MACCE (major adverse cerebral and cardiovascular events)
timeFrame: 6, 12 months
measure: target lesion failure
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Mehmet Akif Ersoy Training and Research Hospital
Study officials:
References:
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