The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions
Coronary Heart Disease
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Active Transfer of Plaque
Eligibility Criteria
Inclusion Criteria:
- Patient must be at least >18, ≤80 years of age.
- Patient has Stable/unstable angina or NSTEMI.
- Patient has STEMI>24-hour from the onset of chest pain to admission.
- Non-left-main coronary bifurcation lesion. (Medina 0,1,1;1,1,1;1,0,1;1,1,0).
- Patient is eligible for elective percutaneous coronary intervention (PCI) .
- Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
- Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations.
Exclusion Criteria:
- Patient with STEMI (within 24-hour from the onset of chest pain to admission).
- Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
- Patient has intolerable to dual anti-platelet therapy.
- Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
- Patient is pregnant or nursing.
- Patient is participating in another clinical trial that has not reached its primary endpoint.
- Patient with severe calcified lesions needing rotational atherectomy.
- Lesions of in-stent restenosis.
- Patients not eligible for this trial based on investigators' judgement.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ATP technique
Provisional T stenting technique
This arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of non-left-main bifurcation lesion.In the ATP technique treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI or stent in SB is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3.
This arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Provisional T stenting technique in the treatment of non-left-main bifurcation lesions.Provisional T stenting technique is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3.