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OCT Explores Vascular Response and Healing Profile After Stenting in CTO

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ClinicalTrials.gov Identifier: NCT03939299
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion of Coronary Artery Procedure: OCT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. long-term minimal stent area [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result

  2. long-term stent thrombosis [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result

  3. long-term stent neointima [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result

  4. long-term stent malapposition [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result

  5. immediately minimal stent area [ Time Frame: in the procedure ]
    measured through OCT imaging result

  6. immediately stent malapposition [ Time Frame: in the procedure ]
    measured through OCT imaging result


Secondary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ Time Frame: 9-12 month after index procedure ]
    clinical follow-up record



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939299


Contacts
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Contact: Hongbo Yang, M.D. 008613585890793 yang.hongbo@zs-hospital.sh.cn
Contact: Zhangwei Chen, Ph.D. 008613918612111 chen.zhangwei@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Hongbo Yang, M.D.    008613585890793    yang.hongbo@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Juying Qian, Professor Fudan University

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03939299     History of Changes
Other Study ID Numbers: CLARIFY-CTO
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
subintimal stenting
vascular response and healing
optical coherence tomography