Calcification, Coronary Artery Disease
Conditions
Keywords
Intravascular lithotripsy, stent under-expansion, calcified coronary lesions
Brief summary
Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure. This study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion/exclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.
Interventions
DEVICEIntravascular lithotripsy group
20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Intravascular lithotripsy group.
DEVICEhigh-pressure balloon group
20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of high-pressure balloon group.
Sponsors
Xuzhou Third People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Radiography inclusion criteria 1. the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis \>20% after stenting and 16-atm dilatation with a post-dilatation balloon; 2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment); 3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment); General inclusion criteria 1. subjects at the age between ≥18 and ≤80 years old; 2. patients with symptoms or evidence of myocardial ischaemia; 3. subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.
Exclusion criteria
* Radiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the thickness of neointima | 12 months |
Contacts
Primary Contactyaojun zhang, Ph.D.
Outcome results
None listed