Chronic Total Occlusion of Coronary Artery
Conditions
Keywords
subintimal stenting, vascular response and healing, optical coherence tomography
Brief summary
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
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.
Interventions
PROCEDUREOCT
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| long-term stent neointima | 9-12 month after index procedure | measured through OCT imaging result |
| long-term minimal stent area | 9-12 month after index procedure | measured through OCT imaging result |
| long-term stent thrombosis | 9-12 month after index procedure | measured through OCT imaging result |
| immediately stent malapposition | in the procedure | measured through OCT imaging result |
| long-term stent malapposition | 9-12 month after index procedure | measured through OCT imaging result |
| immediately minimal stent area | in the procedure | measured through OCT imaging result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events | 9-12 month after index procedure | clinical follow-up record |
Countries
China
Contacts
Primary ContactHongbo Yang, M.D.
Backup ContactZhangwei Chen, Ph.D.
Outcome results
None listed