This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.
Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
The General Hospital of PLA
Beijing, Beijing Municipality, China
RECRUITINGChanges 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.
Time frame: 12 months
Incidence rate of MACE
MACE include composite of death, myocardial infarction, or target-vessel revascularization
Time frame: Incidence rate of MACE from baseline to 12 months
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