Optical Coherence Tomography Clinical Trial
Official title:
Optical Coherence Tomography Compared With Intravascular Ultrasound or Quantitative Coronary Analysis to Guide Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery
This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified lesion in coronary artery.
This clinical trial will enroll 375 subjects and assign to groups in a 1:1:1 ratio (base on
Intravascular Ultrasound [IVUS]-guided treatment group : Optical Coherence Tomography
[OCT]-guided treatment group : Quantitative Coronary Angiography [QCA]-guided treatment
group) who have moderate-severe calcified lesions in de novo native coronary artery with
≥2.50 mm to ≤4.00 mm in diameter (visual measurement) from a maximum of 25 study sites in
China. After the stent is implanted satisfactorily, OCT examinations will be performed on the
subjects of these three groups to observe stent expansion after implantation. At 13 months
after procedure, all subjects will receive QCA examination.
OCT sub-group study: The initial 66 ongoing subjects from the three treatment groups
(IVUS-guided treatment group : OCT-guided treatment group : QCA-guided treatment group) who
provided informed consent and successfully randomized will receive OCT examinations at three
months follow up after baseline procedure.
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