Registry for patients with complex coronary lesions undergoing PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan Zhongshan Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Chenguang Li, Doctor
• Email: li.chenguang@zs-hospital.sh.cn
• Phone: 86+ 13816767665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.