Coronary heart disease
Conditions
Interventions
Case series:NA
Sponsors
Tangdu Hospital, the second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old = age =85 years old; (2) Patients scheduled to undergo DCB, including patients with primary coronary small vessel disease (reference lumen diameter = 2.75 mm) or at least one of the following conditions who are not considered to be suitable candidates for stenting: Non-true bifurcation lesions, diabetes or high bleeding risk (advanced age, concomitant oral anticoagulants, cancer, imminent surgery, etc.), and acute coronary syndrome; (3) The subjects or their representatives voluntarily participated and signed the informed consent, and were willing to undergo relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: (1) ostial lesion of left main coronary artery; (2) Bridging vessels; (3) stent placement in target lesions; (4) tortuous lesions that cannot be passed by OCT catheter; (5) OCT examination did not contain complete target lesions; (6) OCT images could not be interpreted; (7) severe renal impairment (serum creatinine > 2.0mg/dl); (8) New York Heart Association (NYHA) functional class III or IV; (9) participated in other clinical trials within the past 1 month; (10) allergic to contrast media; (11) pregnant or lactating women; (12) previous history of coronary artery bypass grafting; (13) other conditions considered by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of change in drug ball therapy strategy; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2nd angiography compared with 1st angiography, 2ndOCT compared with 1stOCT, whether the degree of dissection produced or aggravated;Incidence of dissection formation after predilation with different plaque properties;Major adverse cardiovascular events;Target lesion failure rate;Adverse events were recorded from the beginning of surgery to 3, 6, and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactLi Yan
Tangdu Hospital, the second Affiliated Hospital of Air Force Medical University
Outcome results
None listed