Calcified Coronary Lesions
Conditions
Brief summary
This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
Detailed description
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.
Interventions
DEVICEIVL(Sonico-CX)
SONICO-CX® balloon matched 1:1 to the reference vessel diameter, was advanced to the target lesion to pretreat
Sponsors
Spectrumedics Medical Technology(Shanghai)Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General inclusion criteria 1. Age ≥ 18 years old 2. Evidence of asymptomatic ischemia, stable or unstable angina 3. Patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to undergo angiography, OCT, and clinical follow-up. * Angiographic Inclusion Criteria 1. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 2. Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm 3. Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation 4. The lesion allows 0.014 guide wires to pass through 5. Under multi-angle contrast conditions, it can be seen that there are calcified angiography lesions on both sides of the lesion blood vessel wall (the target lesion meets the definition of severe calcification).
Exclusion criteria
* General inclusion criteria Patients who fit any of the following criteria were excluded: 1. Acute myocardial infarction occurred within 30 days before procedural 2. Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion 3. Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural 4. Severe cardiac insufficiency (Grade III or IV) 5. Left ventricular ejection fraction \< 40% 6. The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery. 7. Uncontrolled severe hypertension (ystolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg) 8. Severe renal failure (serum creatinine \> 221μmol/L) 9. Preprocedural hemoglobin \< 100g/L 10. Significant coagulation dysfunction (platelet count \< 100×109/L or INR\>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks prior to enrollment) 11. Hypercoagulable blood disorders (e.g. Polycythemia vera, platelet count \>750× 109/L, etc.) 12. History of stroke or TIA within 3 months 13. History of active digestive ulcer or upper gastrointestinal bleeding within 6 months 14. The patients has a life expectancy of less than 12 months 15. The patient has an active systemic infection 16. The patient has a connective tissue disease (such as Marfan's syndrome) 17. The patient is allergic to contrast material 18. Patients undergoing heart transplantation 19. Patients with pacemakers implanted 20. The patient is pregnant or breastfeeding 21. Those who have participated in clinical trials of other drugs or medical devices within 1 month before enrollment 22. Other circumstances that the investigator deems inappropriate to participate in the trial - Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | During hospitalization (up to 7 days after operation) | defined as successful stent implantation with ≤30% in-stent residual stenosis and the absence of in-hospital MACE, including cardiac death, MI, and target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiography success rate | Immediately after operation | Angiographic success was defined as successful stent implantation with ≤30% in-stent residual stenosis and without serious angiographic complications immediately after IVL, including type D to F severe dissection, perforation, acute occlusion, sustained slow-flow, or no-reflow |
| Device success rate | Immediately after operation | Device success was defined as the IVL catheter successfully crossing the target lesion and delivering lithotripsy without serious angiographic complications immediately following the procedure |
| MACE events | before discharge, 30 days and 6 months post-procedural | MACE--a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | before discharge, 30 days and 6 months post-procedural | Incidence of other adverse events during procedural, before discharge, 30 days and 6 months post-procedural |
Countries
China
Outcome results
None listed