µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions
Launched by SHANGHAI ZHONGSHAN HOSPITAL · Aug 4, 2025
Trial Information
Current as of September 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to help doctors decide how to treat certain heart artery problems, specifically when arteries split into branches and a stent (a small tube) is placed in one branch to keep it open. The researchers want to see if a special measurement called µQFR, which looks at blood flow using images from a single view, can accurately show how well blood is flowing in the side branch after placing a stent in the main branch. This could help doctors make better decisions during heart procedures for people with blocked or narrowed arteries.
Adults 18 years and older who have been diagnosed with or are suspected to have coronary artery disease and have a specific type of artery narrowing at a branch point may be able to join. People must have a narrowing of at least 50% in arteries that are 2.5 mm or larger. The study does not include those who recently had a heart attack, severe heart failure, kidney problems, allergies to the dye used in heart imaging, or previous heart bypass surgery. Participants will undergo standard heart imaging and assessments as part of their care, and the study will look at how well the µQFR measurement works in guiding treatment. This trial is not yet recruiting participants but aims to improve how doctors evaluate and treat complex artery narrowing in the heart.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age ≥ 18 years and provision of written informed consent for biospecimen donation upon hospital admission.
- • 2. Clinical suspicion or diagnosis of CAD requiring coronary angiography and physiological assessment.
- • 3. Angiographically confirmed true bifurcation lesions, including but not limited to: left main-left anterior descending-left circumflex (LM-LAD-LCx), left anterior descending-diagonal (LAD-Dg), left circumflex-obtuse marginal (LCx-OM), and right coronary artery-posterior left ventricular-posterior descending artery (RCA-PLV-PDA).
- • 4. Bifurcation lesion vessel diameter ≥ 2.5 mm with visually estimated angiographic diameter stenosis ≥ 50%.
- Exclusion Criteria:
- • 1. Acute myocardial infarction.
- • 2. Cardiogenic shock or severe heart failure (Killip class IV).
- • 3. Serum creatinine \> 150 μmol/L or estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m² calculated using the CKD-EPI formula.
- • 4. Known allergy to iodinated contrast media.
- • 5. History of coronary artery bypass graft surgery.
About Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital is a prestigious medical institution affiliated with Fudan University, renowned for its commitment to advancing healthcare through rigorous clinical research and innovative patient care. With a focus on multidisciplinary collaboration and cutting-edge medical technologies, the hospital conducts a wide range of clinical trials aimed at improving treatment outcomes across various specialties. Its state-of-the-art facilities and highly qualified research team ensure that trials adhere to the highest ethical and scientific standards, contributing significantly to the global body of medical knowledge and enhancing patient health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported