Coronary Artery Disease
Conditions
Interventions
Intravascular Lithotripsy Group:This arm will employ intravascular lithotripsy as the primary calcium modification strategy for lesion preparation.
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) or chronic coronary syndrome (CCS) who are candidates for stent intervention; 3. The target lesion must exhibit moderate superficial calcification, defined as either: Grade II-III calcification (91°-270° intimal calcium arc) at the most severely calcified site by IVUS prior to lesion preparation, or An OCT calcification score of 2-3 points (scored as: maximum calcium arc >180° = 2 points; calcium thickness >0.5mm = 1 point; calcium length >5mm = 1 point); 4. Target lesion must be a de novo lesion in native coronary artery without prior interventional treatment; 5. Target vessel diameter 2.5-4.0mm with successful guidewire crossing of target lesion; 6. Target lesion length =40mm; 7. For patients with multiple lesions, only one lesion shall be selected as the target lesion for this study. If concurrent treatment of both target and non-target lesions is planned: (i) the target and non-target lesions must reside in different vascular branches; (ii) the non-target lesion must be treated first; and (iii) target lesion treatment may only proceed after successful revascularization of the non-target lesion without occurrence of serious angiographic complications; 8. Signed written informed consent obtained;
Exclusion criteria
Exclusion criteria: 1. Life expectancy =2; 10. Non-target vessel revascularization with complications within 30 days prior to randomization; 11. Severe vessel tortuosity/calcification preventing delivery of IVUS-OCT integrated catheter; 12. Bypass graft lesions; 13. Coronary artery dissection; 14. Thrombotic lesions; 15. Severely calcified bifurcation lesions requiring planned two-stent technique; 16. Chronic total occlusion (CTO) lesions; 17. Unprotected left main disease or left main ostial lesions; 18. Aneurysm present within 10mm of target lesion; 19. Planned treatment of target lesion with bare-metal stent, bioresorbable scaffold, or non-stent therapy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal stent area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel failure;Strategy success;In-hospital major adverse cardiac events;Procedural success;The incidence of coronary artery perforation (Ellis type II or higher) demonstrated by angiography after stent implantation;Late lumen loss;Peri-procedural MI;Mean stent expansion rate;The incidence of coronary artery dissection type B or higher as shown by angiography before or after stent implantation;The incidence of modified balloon rupture.;Minimal stent expansion rate;Target lesion failure;30-day major adverse cardiac events;The incidence of branch occlusion after stent implantation;Calcium fracture; | — |
Countries
China
Contacts
Public ContactHuang Xin
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed