OCT Explores Vascular Response and Healing Profile After Stenting in CTO

Fudan University

Status: Unknown

Conditions: Chronic Total Occlusion of Coronary Artery

Treatments: Procedure: OCT

Study type: Interventional

Funder types: Other

Identifiers

NCT03939299

CLARIFY-CTO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

OCT group

Experimental group

Description:

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.

Treatment:

Procedure: OCT