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Randomized Controlled Trial of Simple CROSSover Versus Side Branch Opening on Clinical Outcomes in Patients with Non-Left Main BIfurcation LeSio

Not Applicable
Conditions
Diseases of the circulatory system
Registration Number
KCT0007952
Lead Sponsor
Keimyung University Dongsan Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
1500
Inclusion Criteria

? 19 years of age or older
? Patients with non-left main branch lesions (lateral branch diameter =2.3 mm)
? Target lesions that can be treated with 1-stent with provisional side branch approach according to the judgment of the operator
? In case of collateral branch stenosis after stent insertion in the main branch (more than 50% of stenotic lesions on angiography)

Exclusion Criteria

? Target lesion requiring selective 2-stent technique according to the operator's judgment (Observation group 1)
? Patients who need collateral branch intervention after main branch stent insertion (Observation group 2)
- Decrease in collateral branch blood flow after main branch stent insertion (TIMI flow =2)
- Major dissection of collateral branch after main branch stent insertion (= Type C)
? When collateral branch stenosis did not occur after stent insertion in the main branch (less than 50% of stenotic lesions on angiography) (Observation group 3)
? Cardiogenic shock (Killip class IV) at presentation
? Patients with severe valvular heart disease or severe left ventricular dysfunction (ejection rate <35%)
? Pregnant and lactating women
? Persons who are expected to have a life expectancy of less than 1 year due to non-cardiac disease or to have low adherence to treatment (determined by the investigator by medical judgment)
? Patients who refused to participate in the study

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cardiovascular death, any myocardial infarction [MI, spontaneous or peri-procedural], and clinically driven target lesion revascularization [TLR]
Secondary Outcome Measures
NameTimeMethod
all-cause death;cardiovascular death;any MI;spontaneous MI;target-vessel MI;target-lesion revasuclarization;target-vessel revascularization;Any revascularization;Stent thrombosis;cerebrovascular accident;Bleeding;total procedural time;Total amount of contrast use;Incidence rate of contrast medium-induced renal impairment;Long-term target lesion failure
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