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NCT Number: NCT04789161

Comparison of Double-kissing Crush and Double-kissing Culotte Stenting

True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy. Although the provisional stenting is still effective in suitable lesions, double stent techniques can be required in selected patients. In previous studies, double kissing crush (DK-crush) stenting was revealed as superior to provisional stenting in TBL of left main coronary artery. Additionally, in recent studies, double kissing approach facilitates and highlights double kissing culotte (DK-culotte) stenting with lower stent malapposition compared to DK-crush stenting. However, to the best of our knowledge, there is no study about comparing DK-crush and DK-culotte stenting in TBLs. Our aim in this study is to compare DK-crush and DK-culotte stenting in patients with TBL.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

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

Healthy volunteers accepted: No

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

Treatment and study plan

double kissing crush stenting

Procedure

Patients with true bifurcation lesion treating with double kissing crsuh stenting technique

double kissing culotte stenting

Procedure

Patients with true bifurcation lesion treating with double kissing culotte stenting technique

Primary outcomes

  1. MACE (major adverse cardiovascular events)

    Time frame: 12 months

    target vessel revascularization, myocardial infarction and cardiac death

Secondary outcomes

  1. MACCEs (major adverse cerebral and cardiovascular events)

    Time frame: 12, 24, 36 months

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

  2. target lesion failure

    Time frame: 24, 36 months

    myocardial infarction, cardiac death

Other outcomes

  1. contrast induced nephropathy

    Time frame: 12 months

    25 percent (%) increase in serum creatinine level from baseline or a 0.5 mg/dL increase in absolute serum creatinine value within 72 hours after percutaneous coronary intervention

Sponsors and collaborators

Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Other Gov

Registry information

Official study title

Comparison of Double-kissing Crush and Double-kissing Culotte Stenting in Patients With True Bifurcation Lesion

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2021
Registry last updated
Aug 16, 2024

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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