NCT04789161Completed
Comparison of Double-kissing Crush and Double-kissing Culotte Stenting
Comparison of Double-kissing Crush and Double-kissing Culotte Stenting in Patients With True Bifurcation Lesion
Source: ClinicalTrials.gov · Last updated 16 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 5 Mar 2021
- Start date
- 4 Mar 2021
- Primary completion date
- 4 Apr 2024
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04789161
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 4 Mar 2021 to the primary completion date, 4 Apr 2024
- 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
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 · Does not accept healthy volunteers
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.