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出境医 / 临床实验 / OCT Explores Vascular Response and Healing Profile After Stenting in CTO

OCT Explores Vascular Response and Healing Profile After Stenting in CTO

Study Description
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Juying Qian, Professor Fudan University
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • long-term minimal stent area [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result
  • long-term stent thrombosis [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result
  • long-term stent neointima [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result
  • long-term stent malapposition [ Time Frame: 9-12 month after index procedure ]
    measured through OCT imaging result
  • immediately minimal stent area [ Time Frame: in the procedure ]
    measured through OCT imaging result
  • immediately stent malapposition [ Time Frame: in the procedure ]
    measured through OCT imaging result
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019) 		Major Adverse Cardiovascular Events [ Time Frame: 9-12 month after index procedure ]
clinical follow-up record
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OCT Explores Vascular Response and Healing Profile After Stenting in CTO
Official Title  ICMJE Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Chronic Total Occlusion of Coronary Artery
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Procedure: OCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hongbo Yang, M.D. 008613585890793 yang.hongbo@zs-hospital.sh.cn
Contact: Zhangwei Chen, Ph.D. 008613918612111 chen.zhangwei@zs-hospital.sh.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939299
Other Study ID Numbers  ICMJE CLARIFY-CTO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juying Qian, Professor Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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