Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Oct 7, 2019

Keywords

ClinConnect Summary

The UNIQUE-DCB-II Study is a clinical trial that aims to assess the safety and effectiveness of a treatment called drug-coated balloon (DCB) therapy for patients with a condition known as in-stent restenosis (ISR). ISR occurs when the artery narrows again after a stent has been placed to keep it open. The study will compare this DCB therapy to a newer type of stent called drug-eluting stent (DES) for patients with coronary heart disease. Researchers will use a special method called quantitative flow ratio (QFR) to guide the treatment, which helps identify the severity of artery blockage.

To participate in this trial, patients must have been diagnosed with ISR and have a specific QFR measurement indicating the need for treatment. Key eligibility criteria include being between the ages of 65 and 85 and having no serious heart conditions or other health issues that could complicate the study. Participants will receive either the DCB therapy or the new DES and will be monitored for safety and effectiveness. This study is not yet recruiting, but it is an important step toward finding better treatment options for patients with ISR.

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Eligibility criteria

• Inclusion Criteria:
• • ● Meet the diagnostic criteria for patients with coronary in-stent restenosis and QFR\<0.8 of target lesion in the coronary stent
• Exclusion Criteria:
• • QFR less than 0.8, dissection above type B and thrombosis formation after pre-dilation of ISR
• • 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