Coronary artery disease
Conditions
Interventions
Case series:Use Novasight IVUS-OCT Hybrid catheter to get the image of stent segment
Sponsors
The General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Subject aged 18 to 85 years; 2. Subject is able to verbally confirm understanding the of the risks and benefits of receiving Conavi Novasight Hybrid system and he/she or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee; 3. Percutaneous intervention for the target vessel lesions must be located in a native coronary artery that single stent can fully cover the lesion, and angiography is necessary after the stent implantation.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or cannot eliminate the possibility to be pregnant; 2. Estimated creatinine clearance <30 ml/min/1.73 m2 using Cockcroft equation; 3. LVEF < 35% by the most recent imaging test within 7 days prior to procedure; 4. Unstable ventricular arrhythmias; 5. High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months; 6. Known contraindication to anticoagulants and antiplatelets therapy; 7. Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent; 8. Any intervention for not target vessel within 48 hours after the study procedure; 9. Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation. Angiographic exclusion criteria: 1. The reference diameter of target vessel is less than 2.5 mm; 2. The target lesion involves myocardial bridge; 3. The target lesion is in the left main coronary artery or the damage is observed in the ostium; 4. Severe calcification in the target vessel; 5. Severe tortuosity in the target vessel; 6. Multiple contiguous stent implantation in the target vessel; 7. Subject has coronary artery spasm; 8. In-stent restenosis; 9. Any study lesion characteristic that, in the investigator's opinion, is not available for intravascular imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of clear image length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Success;Technical Success;The ratio of good image in the clinical application;Clear stent length;System reliability of Novasight IVUS-OCT Hybrid System;Catheter operability of Novasight IVUS-OCT Hybrid Catheter; | — |
Countries
China
Contacts
Public ContactGuanlan Song
CardioNavi MedTech (Wuhan) Co.,Ltd.
Outcome results
None listed