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NCT Number: NCT05406284

DK Nano-Culotte Stenting For Coronary Bifurcation Lesion

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Mehmet Akif Ersoy Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

double kissing nano culotte stenting

Procedure

patients with true coronary bifurcation lesion treating with double kissing nano culotte stunting technique

Primary outcomes

  1. MACE (major adverse cardiovascular events)

    Time frame: 12 months

    target lesion revascularization, myocardial infarction or cardiac death

Secondary outcomes

  1. MACCE (major adverse cerebral and cardiovascular events)

    Time frame: 6, 12 months

    all cause death, myocardial infarction, target vessel revascularization, in-stent thrombosis/restenosis or stroke

  2. target lesion failure

    Time frame: 6, 12 months

    target lesion revascularization, myocardial infarction, cardiac death

Sponsors and collaborators

Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Other Gov

Registry information

Official study title

A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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