Complex Higher Risk Indicated Patients Undergoing PCINCT06274645
IVUS CHIP China Registry
An observational study of Complex Higher Risk Indicated Patients Undergoing PCI, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Higher Risk Indicated Patients Undergoing PCI
- What is being tested?
- The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific
- Type of treatment
- Medical device
- How many people
- 2,020 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to Feb 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IVUS-guided approach in patients with complex coronary lesions undergoing PCI
Who may be able to join
- The patient must be ≥18 years of age
- Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
- Angiographic heavy calcification
- Ostial lesions
- True bifurcation lesions involving side-branches >2.5mm
- Left main lesions
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- Chronic total occlusion
- In-stent restenosis
- Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
- Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
- The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
- Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
Who cannot join
- ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
- Known untreated severe valvular heart disease
- Requiring PCI in a diseased aorto-coronary bypass
- Known contraindication or hypersensitivity to anticoagulants
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- Non-cardiac co-morbidities with a life expectancy less than 1 year
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- Currently participating in a clinical trial that is not yet at its primary endpoint. The patient is not allowed to participate in an investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
- Women who are pregnant or who are breastfeeding
- Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junbo Ge, Doctor contact
China1 site, 1 recruiting
- Recruiting
Fudan Zhongshan Hospital
Shanghai
Chenguang Li, Doctor, li.chenguang@zs-hospital.sh.cn
About this study
Official title: Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures China Registry
The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.
- Being tested
- The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston ScientificDevice
The IVUS-guided PCI procedure includes the use of IVUS before PCI (highly recommended) and after PCI (mandatory)
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints.
Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-vessel revascularization at 1 year. It means the time of the patient's occurrence of any of the three events in one year.
Measured: 1 Year
Secondary outcomes (1)
Time-to-first-event analysis will be primarily used for clinical endpoints.
- The time of the first event of Composite of target-vessel myocardial infarction* and clinically indicated target vessel revascularization
- The time of the first event of Clinically-indicated target vessel revascularization
- The time of the first event of Composite of cardiac death and target-vessel myocardial infarction*
- The time of the first event of Target-Lesion Failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-lesion revascularization
- The time of the first event of Target-lesion revascularization
- The time of Cardiac death
Measured: full-time process until 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start12 Mar 2024
- Primary completionJul 2026 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Higher Risk Indicated Patients Undergoing PCIStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,020 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274645
- Sponsor's protocol ID
- IVUS CHIP China Registry
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently,All data of projects will be shared with sponsors and leading site principal investigators. Other site investigators are undecided.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures China Registry
- ClinicalTrials.gov ID
- NCT06274645
- Acronym / sponsor ID
- IVUS CHIP China Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,020 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Feb 2024 (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.
The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IVUS-guided approach in patients with complex coronary lesions undergoing PCI
Key inclusion criteria (13 listed)
- The patient must be ≥18 years of age
- Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
- Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
- The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
Key exclusion criteria (9 listed)
- ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
- Known untreated severe valvular heart disease
- Requiring PCI in a diseased aorto-coronary bypass
- Known contraindication or hypersensitivity to anticoagulants
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
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 |
|---|---|---|
| The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston ScientificThe IVUS-guided PCI procedure includes the use of IVUS before PCI (highly recommended) and after PCI (mandatory) | Device | – |
Primary outcome
Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints.
Time frame: 1 Year
Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-vessel revascularization at 1 year. It means the time of the patient's occurrence of any of the three events in one year.
1 secondary outcome
Time-to-first-event analysis will be primarily used for clinical endpoints.
Time frame: full-time process until 2 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided. Currently,All data of projects will be shared with sponsors and leading site principal investigators. Other site investigators are undecided.
Related trials for Complex Higher Risk Indicated Patients Undergoing PCI
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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.
Junbo Ge, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Higher Risk Indicated Patients Undergoing PCI, 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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenguang Li, Doctor (86+ 13816767665, li.chenguang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints. (time frame: 1 Year). 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 26 Apr 2024.