OCT Explores Vascular Response and Healing Profile After Stenting in CTO

Study Overview
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Brief Summary
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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.

Detailed Description
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Chronic total occlusions (CTOs) are defined as coronary lesions with thrombolysis in myocardial infarction (TIMI) grade flow of 0 and present for more than 3 months. CTO is commonly recognized as the toughest lesion subset to be treated by percutaneous coronary interventions. With the remarkable progress in the technologies and techniques achieved in the PCI for CTO over the last decade, the rate of procedural success increased to 80-90%. Chronic total occlusion is associated with a higher incidence of malapposition and uncovered stent struts. At present, four strategies were used for CTO lesions, including: ante-grade wire escalation, ante-grade dissection reentry (ADR), retro-grade wire escalation, and retrograde dissection reentry (RDR). True-false-true occurred during wire penetration. Subintimal stenting influences vascular response. Intravenous ultrasound (IVUS) confirmed wire position in the procedure. Then stenting procedure was performed according to standard routine. Optical coherence tomography (OCT) was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.

Official Title
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Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion

Conditions
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Chronic Total Occlusion of Coronary Artery

Intervention / Treatment
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* Procedure: OCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT group<br>Patients, whose coronary chronic total occlusion lesion was successfully implanted stent, received optical coherence tomography imaging immediately and at 9-12 months after index procedure. | Procedure: OCT<br>* Patients with coronary chronic total occlusion received successful stenting. Optimal coherence tomography imaged immediately and at 9-12 months after the index procedure to explore long-term vascular response and healing profile.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term minimal stent area | measured through OCT imaging result | 9-12 month after index procedure | 
| long-term stent thrombosis | measured through OCT imaging result | 9-12 month after index procedure | 
| long-term stent neointima | measured through OCT imaging result | 9-12 month after index procedure | 
| long-term stent malapposition | measured through OCT imaging result | 9-12 month after index procedure | 
| immediately minimal stent area | measured through OCT imaging result | in the procedure | 
| immediately stent malapposition | measured through OCT imaging result | in the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | clinical follow-up record | 9-12 month after index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subintimal stenting, vascular response and healing, optical coherence tomography