Angina, Unstable Clinical Trial
Official title:
Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients > 18, < 80 years old, with unstable angina - Single-vessel or double-vessel disease - Length of target lesion < 25mm - Diameter of target vessel >2.5mm, < 3.5mm Exclusion Criteria: - Left main disease - Chronic total occlusion - Severe Tortuosity - Heavy calcification - Severe liver failure, moderate or severe kidney failure - Malignant disease - Active infectious disease - Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
China | The General Hospital of PLA | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Yun Dai Chen |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Target Lumen assessed by optical coherence tomography | A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months. | 12 months | |
Secondary | Incidence rate of MACE | MACE include composite of death, myocardial infarction, or target-vessel revascularization | Incidence rate of MACE from baseline to 12 months |
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