A Study of Drug Coated Balloon For Treating the Side Branch in Complex Bifurcation Lesions (STENT-FREE)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug coated balloon, coronary bifurcation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Meshalkin National Medical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
provisional-stenting group
DCB group
Provisional stenting will be performed according to european bifurcation club consensus. MB and SB predilatation will be at the operator's discretion. A stent is delivered in the main vessel and positioned across the bifurcation. POT is mandatotary. In case of dissection impeding the flow in the SB or acute coronary closure after MB atenting a SB stenting using a DES was allowed. Dual-stent techniques will be performed according to the recommendation of the EBC consensus.
Coronary guidewires should be passed to the MB and SB, respectively. Lesion preparation of the main branch should be undertaken as considered necessary. Lesion preparation of the side branch is mandatorary. If the angiographic result will be good after predilatation (residual stenosis < 30%), drug-eluting stent will implanted in the main branch of the bifurcation site (the stent diameter should be choosen based on the diameter of the distal MB). A kissing with conventional balloons should be performed in the MB and SB. Reapet kissing with drug-coated balloonin the SB and conventional balloon in MB (30 seconds at low pressure (8-10 bar) should be performed. The DCB diameter was again 0.8-1.0 of the vessel diameter. In case of dissection impeding the flow in the SB or acute coronary closure after DCB application a SB stenting using a DES was allowed. Dual-stent techniques will be performed according to the recommendation of the EBC consensus.