Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Sep 24, 2019

Keywords

ClinConnect Summary

The UNIQUE-DCB-I Study is a clinical trial that aims to evaluate a new treatment approach for patients with coronary heart disease (CHD). Specifically, the trial is looking at the safety and effectiveness of drug-coated balloons (DCB) for treating new blockages in the heart arteries, using a special imaging technique called quantitative flow ratio (QFR) to guide the procedure. This method helps doctors see how severe the blockage is and make better treatment decisions. DCB therapy is promising because it may reduce the risk of complications like restenosis (re-narrowing of the artery) without leaving behind metal stents, which can sometimes cause issues.

To participate in this trial, individuals must be diagnosed with stable or unstable angina (chest pain) or have had a heart attack, and their blockage must meet specific criteria using the QFR measurement. However, there are some exclusions, such as having certain severe heart conditions or allergies to specific medications used during the procedure. Participants can expect to receive close monitoring and care throughout the study to ensure their safety. Overall, this trial could lead to new, effective treatments for patients with CHD, particularly for those with complex artery blockages.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • ●Meet the diagnostic criteria for stable angina pectoris, unstable angina pectoris and acute myocardial infarction and QFR\<0.8 of target lesion
• Exclusion Criteria:
• • QFR less than 0.8, dissection above type B and thrombosis formation after pre-dilation of coronary artery lesions
• • Severe congestive heart failure \[LVEF \<30% or NYHA( New York Heart Association) III/IV)\]
• • Severe valvular heart disease
• • Life expectancy no more than 1 year or factors causing difficulties in clinical follow up
• • Intolerance to aspirin and/or clopidogrel
• • Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy
• • Leukopenia or thrombopenia
• • A history of peptic ulcer or GI bleeding in the previously
• • Stroke within 6 months prior to the operation
• • A history of severe hepatic or renal failure