coronary atherosclerotic heart disease
Conditions
Interventions
Test group:Post-dilation with isodiametric rapamycin eluting balloon to treat high-risk tissue prolapse in coronary stents
Control group:Post-dilation with isodiametric non-compliant balloon to treat high-risk tissue prolapse in coronary stents
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Coronary angiogram confirmed ischemia-associated vascular stenosis >=70% with coronary artery diameter >=2.5mm; Percutaneous coronary intervention was successfully achieved with second-generation drug-eluting stent implantation; 2. Patients with confirmed high-risk in-stent tissue prolapse after PCI confirmed by OCT imaging; 3. Male or non-pregnant female aged 18 to 80 years; 4. Volunteered to participate in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patiens with severe liver and kidney dysfunction, serum ST/ALT level is more than 3 times of the upper limit of reference range; history of cirrhosis or eGFR less than 30ml/min/1.73m2 is not suitable for angiography; 2. Patients diagnosis with acute ST-segment elevation myocardial infarction within 3 days or coronary SYNTAX score is greater than 32 points or compelete revasculization is not achieved by PCI althrough artery bypass surgery was refused; 3. The presence of life-threatening arrhythmia or hemodynamic instability, cardiogenic shock, IABP used, Mobitz ii type 2 or more severity atrioventricular block; 4. Patients diagnosis with congestive heart failure (NYHA=4,LVEF4.0mm, chronic complete occlusion lesions or blood flow is lower than TIMI3 grade after stent implantation and bifurcation lesion with planned dual stent strategy is not suitable for the experiment; 6. Imaging vessel is too tortuous resulting in uncomplete OCT imaging examination because of severe calcification lesions; 7. Coagulation dysfunction or significant bleeding tendency (such as allergy, active bleeding, past history of intracranial hemorrhage, history of gastrointestinal bleeding within 6 months and history of bypass surgery within 30 days); 8. Patients with severe immunodeficiency diseases (such as HIV), malignancies, autoimmune diseases, blood system diseasesor life expectancy is less than three years; 9. Patients can not adherence to standard dual antiplatelet therapy or known allergic to contrast medium is not suitable for the experiment; 10. Attending participants who have participated in any clinical trial within 1 month before surgery or outright reject current investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| minimum stent area;late lumen loss;scaffold neointimal area; | — |
Secondary
| Measure | Time frame |
|---|---|
| major adverse cardiac events,MACE;Contrast-Induced Acute Kidney Injury; | — |
Countries
China
Contacts
Public ContactGuo Tao
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed