Status:
UNKNOWN
A Study of Drug Coated Balloon For Treating the Side Branch in Complex Bifurcation Lesions
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Hypothesis: In patients undergoing coronary stenting for the true bifurcation lesions, main branch stenting followed by side branch dilatation with drug coated balloon is superior to the provisional-s...
Detailed Description
Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent an alternative therapeutic strategy in certain anatomic co...
Eligibility Criteria
Inclusion
- Main branch and side branch diameter both \>2.5 mm, evaluated based on coronary angiography, performed no later than 6 month before baseline visit;
- Patient ≥18 years old;
- Signed informed consent;
- True bifurcation lesion type 1:1:1 or 0:1:1 or 1:0:1 and
- ischemic symptoms, or
- positive non-invasive imaging for ischemia, or
- positive fractional flow reserve
Exclusion
- ST Elevation Miocardial Infarction \<72 hours preceding;
- Cardiogenic shock;
- Chronic total occlusion of either main or side branch of the bifurcation;
- \>2 other coronary lesions planned for treatment;
- SYNTAX score \>32;
- Left main stenosis;
- In-stent restenosis;
- Renal function insufficiency: Serum creatinine \> 177 mmol/l; or undergoing hemodialysis;
- Left ventricular ejection fraction ≤ 30%;
- Patient life expectancy less than 12 months;
- Patient's inability to fully cooperate with the study protocol
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05222061
Start Date
February 15 2022
End Date
February 15 2023
Last Update
February 3 2022
Active Locations (1)
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1
Meshalkin National Medical Research Center
Novosibirsk, Novosibirsk Oblast, Russia, 630055