OCT Explores Vascular Response and Healing Profile After Stenting in CTO

NCT03939299 | Unknown

• 1 other identifier: CLARIFY-CTO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

subintimal stenting; vascular response and healing; optical coherence tomography

Outcome Measures

Primary Outcomes (6)

• long-term minimal stent area

  measured through OCT imaging result

  9-12 month after index procedure

• long-term stent thrombosis

  measured through OCT imaging result

  9-12 month after index procedure

• long-term stent neointima

  measured through OCT imaging result

  9-12 month after index procedure

• long-term stent malapposition

  measured through OCT imaging result

  9-12 month after index procedure

• immediately minimal stent area

  measured through OCT imaging result

  in the procedure

• immediately stent malapposition

  measured through OCT imaging result

  in the procedure

Secondary Outcomes (1)

• Major Adverse Cardiovascular Events

  9-12 month after index procedure

Study Arms (1)

OCT group

EXPERIMENTAL

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

Interventions

OCT PROCEDURE

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.

OCT group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Juying Qian, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbo Yang, M.D.

CONTACT

008613585890793; yang.hongbo@zs-hospital.sh.cn

Zhangwei Chen, Ph.D.

CONTACT

008613918612111; chen.zhangwei@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 6, 2019
• Study Start: April 15, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

CN (1)