Intravascular Lithotripsy
Conditions
Brief summary
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.
Detailed description
In order to investigate the effectiveness and safety of intravascular lithotripsy(IVL) in patients with calcium induced stent insufficiency, we designed a prospective, randomized, controlled, single blind, multicenter, and superior efficacy clinical trial. We include a real-world population of patients who had stent underexpansion due to calcification detected by intravascular ultrasound(IVUS) in the target vessel after percutaneous coronary intervention(PCI) and met the inclusion and exclusion criteria. In addition to routine clinical treatment, IVUS testing was performed on patients after PCI. Patients who met the criteria for stent underexpansion detected by IVUS are randomly divided into two groups. The experimental group received IVL intervention on the basis of high-pressure balloon post-dilation, while the control group received more aggressive high-pressure balloon post-dilation treatment. The satisfaction rate of stent dilation detected by IVUS in both groups after IVL or high-pressure balloon post-dilation was taken as the main efficacy endpoint. MACE events (composed of cardiovascular death, target vessel myocardial infarction and target vascular revascularization) from PCI to one-year follow-up are evaluated. And the acquisition of lumen after treatment is used as other secondary efficacy endpoints. We use postoperative complications such as coronary artery spasm, dissection, acute occlusion, and persistent ventricular arrhythmia as safety endpoints.
Interventions
The intravascular lithotripsy can intermittently release acoustic pressure waves at the site of vascular calcification lesions, thereby achieving the goal of rupturing calcified plaques; After the rupture of calcified plaques, the vascular calcification lesions can be fully dilated with the help of lower balloon inflation pressure.
DEVICEhigh-pressure ballon
High pressure balloon dilation, as the main method for traditional treatment of insufficient stent expansion caused by calcification, has a good therapeutic effect on insufficient stent expansion caused by calcification
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18-80 years old, male or non pregnant female 2. The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up 3. Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time\>24 hours, as well as old myocardial infarction patients 4. Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia 5. The target lesion is the only lesion that requires treatment this time 6. Patients suitable for percutaneous coronary stent implantation 7. Confirmed by coronary angiography or IVUS testing that the target lesion is calcified, with any degree of calcification 8. After surgical treatment for calcified lesions, IVUS testing confirmed that it meets the criteria for incomplete stent expansion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Rate of Stent Expansion[Effcacy] | immediately after percutaneous coronary intervention(PCI) | Satisfied stent expansion is defined as meeting the standard of good expansion after stent implantation through IVUS after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Events[Effcacy] | 1 year after after percutaneous coronary intervention(PCI) | a composite endpoint of cardiovascular death, target vessel myocardial infarction and target vessel revascularization |
| Lumen Obtainment after PCI[Effcacy] | immediately after percutaneous coronary intervention(PCI) | changes in lumen area after treatment |
| Incidence of Treatment-Emergent Complications[Safety] | immediately after percutaneous coronary intervention(PCI) | Postoperative complications such as coronary spasm, dissection, acute occlusion, persistent ventricular arrhythmia, etc |
Contacts
Primary ContactKefei Dou, Doctor
Backup ContactBowen Li, bachelor
Outcome results
None listed