Registry for patients with complex coronary lesions undergoing PCI
Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures China Registry
This study is testing if using special ultrasound tools during heart procedures can help people with complex coronary blockages feel better and stay healthy for longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2020 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06274645 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical efficacy and safety of an intravascular ultrasound (IVUS)-guided approach in patients with complex coronary lesions undergoing percutaneous coronary intervention (PCI). Participants will be treated using the OptiCross High Definition and OptiCross IVUS catheters from Boston Scientific. The study will track clinical outcomes for up to two years to assess the effectiveness of this approach in improving patient care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific complex coronary lesions requiring PCI.
Not a fit: Patients without complex coronary lesions or those not requiring PCI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of PCI procedures for patients with complex coronary conditions.
How similar studies have performed: Other studies have shown promising results with IVUS-guided approaches in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient must be ≥18 years of age 2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria: 1. Angiographic heavy calcification 2. Ostial lesions 3. True bifurcation lesions involving side-branches \>2.5mm 4. Left main lesions 5. Chronic total occlusion 6. In-stent restenosis 7. 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 3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS) 4. 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) 5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion 6. 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 Exclusion Criteria: 1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days 2. Known untreated severe valvular heart disease 3. Requiring PCI in a diseased aorto-coronary bypass 4. Known contraindication or hypersensitivity to anticoagulants 5. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors 6. Non-cardiac co-morbidities with a life expectancy less than 1 year 7. 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 8. Women who are pregnant or who are breastfeeding 9. Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion)
Where this trial is running
Shanghai
- Fudan Zhongshan Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chenguang Li, Doctor
- Email: li.chenguang@zs-hospital.sh.cn
- Phone: 86+ 13816767665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.