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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Optical Coherence Tomography
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Enrollment
- 375
- Locations
- 1
- Primary Endpoint
- in-stent late loss
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must be 18 to 80 years age
- •Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
- •Subject is eligible for percutaneous coronary intervention (PCI);
- •Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia (including NST-ACS, stable CAD and STEMI（duration over 4 weeks）);
- •Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
- •Left ventricular ejection fraction (LVEF) detected by cardiac ultrasound within 30 days ≥ 30%;
- •Subject is willing to comply with all protocol-required follow-up evaluation.
- •Angiographic Inclusion Criteria (visual estimate):
- •The target lesion must be a new lesion and has moderate-to-severe calcification which located in a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in native coronary artery;
- •Target lesion diameter stenosis ≥70% and ≤99%
Exclusion Criteria
- •Subjects recently suffer from STEMI (within 4 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) , and if any of the following criteria is meet in the procedure, patients are excluded; CK-MB\> 2ULN, regardless of the value of total CK; total CK\> 2ULN, CK-MB or Tn is abnormal;
- •If CK-MB or CK was not detected, but cTN\> 1ULN, and at least one of the following:
- •schemic symptoms and ECG changes of new ischemia; Development of pathologic Q waves in the ECG; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- •Subject with hemodynamic instability or severely decreased activity tolerance (KILLIP classification \>2 or NYHA classification \>2 );
- •Severely ejection fraction reduced heart failure ( LVEF \< 30%)
- •Subjects were detected ventricular aneurysm greater than 3.0\*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;
- •Subjects had an organ transplant or are waiting for an organ transplant;
- •Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
- •Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
- •Subjects have confirmed or suspected liver disease, including hepatitis lab results;
Outcomes
Primary Outcomes
in-stent late loss
Time Frame: 13 months
the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 13 months after the procedure
Secondary Outcomes
- instant Minimum Stent Area (MSA)(during PCI procedure)
- stent neointimal thickness(3 months)