EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation
Launched by SHANGHAI 10TH PEOPLE'S HOSPITAL · Jul 15, 2021
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a specific condition called chronic total occlusion (CTO) of the coronary artery, which means that a part of the heart's blood supply is completely blocked. Researchers want to learn more about how certain characteristics of the blockage can help predict complications during and after a procedure called stent implantation, which is used to open up blocked arteries. They will use a special imaging technique called intravascular ultrasound (IVUS) to evaluate the blockage and gather important information about it.
To participate in this trial, you need to be between 18 and 80 years old and diagnosed with CTO in a major coronary artery that is at least 2.5 millimeters wide. However, some people may not be eligible, including those who have had a recent heart attack, certain severe health conditions, or who cannot take specific medications. If you qualify and decide to participate, you will undergo evaluations and follow-up care to monitor your health throughout the study. This trial is currently not recruiting participants, but it aims to provide valuable insights that could improve treatment for patients with coronary artery blockages in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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);
- • 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.
About Shanghai 10th People's Hospital
Shanghai 10th People's Hospital, affiliated with Tongji University, is a leading clinical research institution in China known for its commitment to advancing medical science and improving patient care. With a focus on innovative therapies and cutting-edge research methodologies, the hospital conducts a wide range of clinical trials across various medical disciplines. Its state-of-the-art facilities and multidisciplinary team of experts enable rigorous study designs and high-quality data collection, fostering collaboration with both national and international partners. The hospital is dedicated to upholding ethical standards and promoting patient safety, ensuring that its clinical trials contribute significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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