Clinical trial NCT03939299: OCT Explores Vascular Response and Healing Profile After Stenting in CTO
Official title: Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: subintimal stenting
vascular response and healing
optical coherence tomography
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: long-term minimal stent area
timeFrame: 9-12 month after index procedure
measure: long-term stent thrombosis
timeFrame: 9-12 month after index procedure
measure: long-term stent neointima
timeFrame: 9-12 month after index procedure
measure: long-term stent malapposition
timeFrame: 9-12 month after index procedure
measure: immediately minimal stent area
timeFrame: in the procedure
measure: immediately stent malapposition
timeFrame: in the procedure
Secondary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 9-12 month after index procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Juying Qian, Professor
role: PRINCIPAL_INVESTIGATOR
References: