Chronic Total Occlusion of Coronary ArteryNCT03939299
OCT Explores Vascular Response and Healing Profile After Stenting in CTO
A study testing OCT in people with Chronic Total Occlusion of Coronary Artery, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- OCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- Active bleeding;
- Bleeding diathesis or coagulopathy, malignant tumors;
- Contraindication of anticoagulant drugs;
- Subjects with other situation not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Hongbo Yang, M.D., 008613585890793, yang.hongbo@zs-hospital.sh.cn
About this study
Official title: Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
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.
Read the 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.
- Being tested
- OCT
- Keywords
- subintimal stenting, vascular response and healing, optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term minimal stent area
measured through OCT imaging result
Measured: 9-12 month after index procedure
long-term stent thrombosis
measured through OCT imaging result
Measured: 9-12 month after index procedure
long-term stent neointima
measured through OCT imaging result
Measured: 9-12 month after index procedure
long-term stent malapposition
measured through OCT imaging result
Measured: 9-12 month after index procedure
immediately minimal stent area
measured through OCT imaging result
Measured: in the procedure
immediately stent malapposition
measured through OCT imaging result
Measured: in the procedure
Secondary outcomes (1)
Major Adverse Cardiovascular Events
clinical follow-up record
Measured: 9-12 month after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start15 Apr 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juying Qian, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939299
- Sponsor's protocol ID
- CLARIFY-CTO
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT03939299
- Acronym / sponsor ID
- CLARIFY-CTO
- Keywords
- subintimal stenting, vascular response and healing, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients received optical coherence tomography examination after successful stening at the chronic total occlusion lesion.
| Arm | Type | Receives |
|---|---|---|
| OCT group | Experimental | Procedure: OCTPatients, whose coronary chronic total occlusion lesion was successfully implanted stent, received optical coherence tomography imaging immediately and at 9-12 months after index procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTPatients 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. | Procedure or surgery | OCT group |
Primary outcome
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
1 secondary outcome
Major Adverse Cardiovascular Events
Time frame: 9-12 month after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juying Qian, Professor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT in people with Chronic Total Occlusion of Coronary Artery, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbo Yang, M.D. (008613585890793, yang.hongbo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term minimal stent area (time frame: 9-12 month after index procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.