Comparison of Double-kissing Crush and Double-kissing Culotte Stenting
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| double kissing crush stenting patients with true bifurcation lesion undergoing double kissing crush stenting |
Procedure: double kissing crush stenting
Patients with true bifurcation lesion treating with double kissing crsuh stenting technique
|
| double kissing culotte stenting patients with true bifurcation lesion undergoing double kissing culotte stenting |
Procedure: double kissing culotte stenting
Patients with true bifurcation lesion treating with double kissing culotte stenting technique
|
Outcome Measures
Primary Outcome Measures
- MACE (major adverse cardiovascular events) [12 months]
target vessel revascularization, myocardial infarction and cardiac death
Secondary Outcome Measures
- MACCEs (major adverse cerebral and cardiovascular events) [12, 24, 36 months]
all cause death, myocardial infarction, target lesion revascularization, target lesion revascularization, in-stent thrombosis and/or restenosis, stroke
- target lesion failure [24, 36 months]
myocardial infarction, cardiac death
Other Outcome Measures
- contrast induced nephropathy [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
Eligibility Criteria
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:
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Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
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Patients with a history of coronary artery bypass grafting surgery
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Patients with a chronic total occlusion in the bifurcation area
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Lesions with severe calcification that needs additional intervention such as atherectomy
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Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
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Patients with hematological disorders, malignancy, end stage renal (GFR<30 ml/min) and hepatic failure
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Patients with active bleeding
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Pregnant women
-
Patients with life-expectancy < 1 year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istanbul Mehmet Akif Ersoy Training and Research Hospital | Istanbul | Turkey | 34303 |
Sponsors and Collaborators
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMAEETH-2