OCT Explores Vascular Response and Healing Profile After Stenting in CTO

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03939299
• Other study ID #: CLARIFY-CTO
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Hongbo Yang, M.D.
• Phone: 008613585890793
• Email: yang.hongbo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Intervention

Procedure:
• OCT
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.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term minimal stent area	measured through OCT imaging result	9-12 month after index procedure
Primary	long-term stent thrombosis	measured through OCT imaging result	9-12 month after index procedure
Primary	long-term stent neointima	measured through OCT imaging result	9-12 month after index procedure
Primary	long-term stent malapposition	measured through OCT imaging result	9-12 month after index procedure
Primary	immediately minimal stent area	measured through OCT imaging result	in the procedure
Primary	immediately stent malapposition	measured through OCT imaging result	in the procedure
Secondary	Major Adverse Cardiovascular Events	clinical follow-up record	9-12 month after index procedure