coronary heart disease
Conditions
Interventions
Experimental group:Immediate intracoronary injection of 4mL of 0.9% NaCl solution containing 4mg of TNK following balloon angioplasty (dilation).
Control group:Immediate intracoronary injection of 4mL of 0.9% NaCl solution following balloon angioplasty (dilation).
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) age =18 years; (2) CAD patients clinically recommended for elective PCI; (3) IVUS confirms lesion length = 20mm and meets the characteristics of EA: plaque showing ultrasound signal attenuation (longitudinal attenuation length =5mm), excluding calcified and dense fibrous plaques; (4) acceptance of terms and conditions of the study and signature of the informed consent form, with a full understanding of the trial content, process, and potential adverse reactions; willing to adhere to medical follow-up.
Exclusion criteria
Exclusion criteria: (1) positive cardiac troponin I (cTnI) prior to percutaneous coronary angiography; (2) coronary artery bypass graft (CABG) lesion; (3) chronic total occlusion (CTO); (4) in-stent restenosis; (5) severe calcification; (6) left main coronary artery disease (LMCAD); (7) intervention of > 1 major coronary artery branch in a single PCI procedure; (8) side branch occlusion or blood flow-affecting dissection during PCI; (9) cardiogenic shock during PCI; (10) vulnerable populations, including individuals with mental disorders, cognitive impairment, critical illness, minors, female participants in pregnancy/lactation or positive pregnancy tests, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of PCI-related MI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with elevated postoperative high-sensitivity cTnI exceeding 5, 10, 35, and 70 times of the normal baseline.;Incidence of slow-flow after stent implantation and post-dilation;Frame count of angiographic flow after stent implantation and post-dilation.;Incidence of MACE during hospitalization and post-operative 1-month follow up.; | — |
Countries
China
Contacts
Public Contactzhang wenbin
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed