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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007952

Enrollment

1500

Registered

2022-12-02

Start date

2023-01-02

Completion date

Unknown

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Comparison of clinical progress between simple crossover and side branch opening strategies for collateral branch stenosis lesions

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Cardiovascular death, any myocardial infarction [MI, spontaneous or peri-procedural], and clinically driven target lesion revascularization [TLR]	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactSoYoung Kwon

Keimyung University Dongsan Hospital

sykwon.cv@gmail.com+82-53-258-6663

Outcome results