Chronic Total Occlusion of Coronary ArteryNCT04965207
EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation
An observational study of Chronic Total Occlusion of Coronary Artery, run by Shanghai 10th People's Hospital.
Trial summary
IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 31 Dec 2025
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing CTO PCI at each of the participating centers
Who may be able to join
- 18 to 80 years old;
- be diagnosed with CTO;
- CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5mm;
- comply with all the evaluations and follow-up protocols.
Who cannot join
- suffered from acute myocardial infarction within the previous 3 months;
- rheumatic valvular disease;
- severe arrhythmia;
- lesions unsuitable for PCI;
- severely abnormal hematopoietic systems, such as platelet counts <100*10^9/L or > 700*10^9/L and white blood cell counts < 3*10^9/L;
- with active bleeding or bleeding tendencies(active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency);
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- severe coexisting conditions, including severe renal function dysfunction [Glomerular filtration rate less than 60ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months;
- a life expectancy less than 12 months;
- pregnancy or planning to become pregnant;
- history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents;
- cannot tolerate dual antiplatelet treatment;
- unable to communicate due to cognitive impairment, auditory, or visual impairment;
- participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation (LAOHUOJI): a CTO All-comer Register Study
IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO.
Read the detailed description
At present, novel technologies of CTO interventional therapy become mature. These technologies usually artificially cause dissection of coronary artery. The events such as collateral vessel loss, vascular injury and tear, perforation, pericardial tamponade caused by false lumen may theoretically affect the perioperative and long-term prognosis of patients. In this study, intravascular ultrasound (IVUS) was used to evaluate the characteristics of true lumen and false lumen in CTO segment, so as to determine its impact on the prognosis of patients.
- Keywords
- Chronic Total Occlusion, Intravascular Ultrasound, Percutaneous Coronary Intervention, True Lumen, False Lumen
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss
Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up.
Measured: 1 year after PCI
Secondary outcomes (3)
Late Lumen Loss
Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up.
Measured: 3 year after PCI
Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE)
including any of the following adverse events before hospital discharge: death from any cause, Q-wave myocardial infarction, recurrent symptoms Heart and Vessels requiring urgent repeat target vessel revascularization with PCI or CABG, tamponade requiring either pericardiocentesis or surgery, and stroke.
Measured: Within the first week after PCI, at the 1-year follow-up and at the 3-year follow-up
Complications
Any periprocedural complication was defined as the composite of death, myocardial infarction, stent thrombosis, stroke, vessel perforation, vascular access complications, need for emergency surgical intervention or PCI, and hemoglobin reduction by >3 g/dL.
Measured: Within the first week after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965207
- Sponsor's protocol ID
- LAOHUOJI
- Status last verified
- Sep 2021
- First submitted
- 11 Jul 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation (LAOHUOJI): a CTO All-comer Register Study
- ClinicalTrials.gov ID
- NCT04965207
- Acronym / sponsor ID
- LAOHUOJI
- Keywords
- Chronic Total Occlusion, Intravascular Ultrasound, Percutaneous Coronary Intervention, True Lumen, False Lumen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Xijing Hospital
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jul 2021 (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.
IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO.
Detailed description
At present, novel technologies of CTO interventional therapy become mature. These technologies usually artificially cause dissection of coronary artery. The events such as collateral vessel loss, vascular injury and tear, perforation, pericardial tamponade caused by false lumen may theoretically affect the perioperative and long-term prognosis of patients. In this study, intravascular ultrasound (IVUS) was used to evaluate the characteristics of true lumen and false lumen in CTO segment, so as to determine its impact on the prognosis of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing CTO PCI at each of the participating centers
Key inclusion criteria (4 listed)
- 18 to 80 years old;
- be diagnosed with CTO;
- CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5mm;
- comply with all the evaluations and follow-up protocols.
Key exclusion criteria (13 listed)
- suffered from acute myocardial infarction within the previous 3 months;
- rheumatic valvular disease;
- severe arrhythmia;
- lesions unsuitable for PCI;
- severely abnormal hematopoietic systems, such as platelet counts <100*10^9/L or > 700*10^9/L and white blood cell counts < 3*10^9/L;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Late Lumen Loss
Time frame: 1 year after PCI
Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up.
3 secondary outcomes
Late Lumen Loss
Time frame: 3 year after PCI
Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE)
Time frame: Within the first week after PCI, at the 1-year follow-up and at the 3-year follow-up
Complications
Time frame: Within the first week after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion of Coronary Artery, run by Shanghai 10th People's Hospital.
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 13 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Hu Tao, M.D. (13363999556, dr_ht556@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Lumen Loss (time frame: 1 year after PCI). 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 28 Sep 2021.