Coronary Artery Disease
Conditions
Brief summary
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries. And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
Interventions
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. older than 60 years of age. * 2\. meeting the indications for coronary intervention. * 3\. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) ; * 4\. Target lesion vessel diameter \> 2.75 mm
Exclusion criteria
* 1\. inability to provide written informed consent. * 2\. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc. * 3\. the subject is participating in another uncompleted clinical trial * 4\. life expectancy \<1 year. * 5\. non-in situ vascular lesions. * 6\. cardiogenic shock. * 7\. Patients with hemodynamic instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LLL | 12 months | Late lumen loss (LLL) of the target lesion segment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge | Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction |
Countries
China
Contacts
STUDY_CHAIRMuwei Li, MD
Fuwai central China cardiovascular hospotial
Outcome results
None listed