Other Clinical Trial - IVUS CHIP China Registry

Clinical 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. Participants will be treated with IVUS-guided PCI.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06274645
Study type	Observational [Patient Registry]
Source	Shanghai Zhongshan Hospital
Contact	Chenguang Li, Doctor
Phone	86+ 13816767665
Email	li.chenguang@zs-hospital.sh.cn
Status	Recruiting
Phase
Start date	March 12, 2024
Completion date	February 2028

IVUS CHIP China Registry

Clinical Trial Summary

Clinical Trial Description

Study Design