Chronic Total Occlusion of Coronary Artery Clinical Trial
Official title:
Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
True-false-true occurred during wire penetration in coronary CTO procedure. Subintimal stenting influences vascular response. Intravenous ultrasound confirmed wire position in the procedure. Then stenting procedure was performed. Optical coherence tomography was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 18~85 years old; - Agree percutaneous coronary intervention without related contraindications; - Chronic total occlusion confirmed by clinical and angiographic data, predicted high successful rate of stent implantation; - Subjects (or legal guardians) understanding the testing requirements and procedures, and providing written informed consent. Exclusion Criteria: - Subjects associated with drugs allergy (such as contrast, sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin); - Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy; - Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months; - Pregnant or breastfeeding women; - Refused this trial; - Subjects with severe liver or renal dysfunction (ALT >5×ULN,eGFR< 30ml/min/1.73mm2 or Scr>200 mmol/L); - Active bleeding; - Bleeding diathesis or coagulopathy, malignant tumors; - Contraindication of anticoagulant drugs; - Subjects with other situation not suitable for the study. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | long-term minimal stent area | measured through OCT imaging result | 9-12 month after index procedure | |
Primary | long-term stent thrombosis | measured through OCT imaging result | 9-12 month after index procedure | |
Primary | long-term stent neointima | measured through OCT imaging result | 9-12 month after index procedure | |
Primary | long-term stent malapposition | measured through OCT imaging result | 9-12 month after index procedure | |
Primary | immediately minimal stent area | measured through OCT imaging result | in the procedure | |
Primary | immediately stent malapposition | measured through OCT imaging result | in the procedure | |
Secondary | Major Adverse Cardiovascular Events | clinical follow-up record | 9-12 month after index procedure |
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