OCT Explores Vascular Response and Healing Profile After Stenting in CTO
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 04/30/2019 |
| Primero enviado: | 04/28/2019 |
| Inscripción estimada enviada: | 05/02/2019 |
| Publicado por primera vez: | 05/05/2019 |
| Última actualización enviada: | 05/02/2019 |
| Última actualización publicada: | 05/05/2019 |
| Fecha de inicio real del estudio: | 04/14/2019 |
| Fecha estimada de finalización primaria: | 12/30/2023 |
| Fecha estimada de finalización del estudio: | 12/30/2023 |
Condición o enfermedad
Intervención / tratamiento
Procedure: OCT group
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: OCT group 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 group 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. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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. |
Salir
Medidas de resultado primarias
1. long-term minimal stent area [9-12 month after index procedure]
2. long-term stent thrombosis [9-12 month after index procedure]
3. long-term stent neointima [9-12 month after index procedure]
4. long-term stent malapposition [9-12 month after index procedure]
5. immediately minimal stent area [in the procedure]
6. immediately stent malapposition [in the procedure]
Medidas de resultado secundarias
1. Major Adverse Cardiovascular Events [9-12 month after index procedure]
