NCT06787547
Completed
Not Applicable
A Prospective, Multi-center, Single-arm, Objective Performance Goal Pre-specified Study to Evaluate the Safety and Effectiveness of Intravascular Lithotripsy Generator Combined with SONICO-CX Coronary Intravascular Lithotripsy (IVL) Catheter for Pre-treatment of Coronary Calcification Before Stent Implantation
Spectrumedics Medical Technology(Shanghai)Co.,Ltd11 sites in 1 country266 target enrollmentStarted: December 1, 2021Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
- Enrollment
- 266
- Locations
- 11
- Primary Endpoint
- Procedural success rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General inclusion criteria
- •Age ≥ 18 years old
- •Evidence of asymptomatic ischemia, stable or unstable angina
- •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
- •The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
- •Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm
- •Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation
- •The lesion allows 0.014 guide wires to pass through
- •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:
- •Acute myocardial infarction occurred within 30 days before procedural
- •Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion
- •Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural
- •Severe cardiac insufficiency (Grade III or IV)
- •Left ventricular ejection fraction \< 40%
- •The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery.
- •Uncontrolled severe hypertension (ystolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg)
- •Severe renal failure (serum creatinine \> 221μmol/L)
Outcomes
Primary Outcomes
Procedural success rate
Time Frame: 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 Outcomes
- Angiography success rate(Immediately after operation)
- Device success rate(Immediately after operation)
- MACE events(before discharge, 30 days and 6 months post-procedural)
Investigators
Study Sites (11)
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