Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II)
Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Oct 7, 2018
Trial Information
Current as of June 14, 2025
Completed
Keywords
ClinConnect Summary
The current study is designed as a multicenter, randomized and prospective study aiming to compare the incidence rate of RA-related myocardial injury indicated by change in levels of myocardial injury biomarkers (such as TNI and CK-MB) between low temperature rota-flush solution group and room temperature rota-flush solution group. Based on previous study, the incidence rate of RA-related myocardial injury is 68.0 % in patients with severe calcified lesions undergoing PCI. And in our study the expected incidence rate of RA-related myocardial injury is up to 34.0 % in patients with severe ca...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • De novo lesions
- • Severe coronary calcified lesion (detected by CAG, IVUS or OCT)
- • New generation drug eluting stent implantation
- • Only single coronary artery treated at this time
- Exclusion Criteria:
- • Those who meet the diagnostic criteria of acute myocardial infarction
- • Patients with cardio-genic shock
- • Patients with multiple organ failure
- • Patients allergic to contrast
- • Patients who can not tolerate dual antiplatelet therapy
- • Patients who can't tolerate anticoagulation
- • Recently infected patients
- • Patients with hepatorenal dysfunction
- • Thrombotic lesion of coronary artery
- • Spontaneous coronary dissection
- • Patients with drug coated balloon treatment
- • Patients with bioabsorbable vascular scaffold implantation
- • Previous percutaneous coronary intervention or coronary artery bypass graft
- • Patients with active stage of autoimmune disease
- • Patients with complex coronary bifurcation requiring two stent strategy
About Nanjing First Hospital, Nanjing Medical University
Nanjing First Hospital, affiliated with Nanjing Medical University, is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care and cutting-edge medical practices, the hospital serves as a key player in the development of new therapies and treatment protocols. Its collaborative environment fosters interdisciplinary research, enabling the integration of scientific inquiry with clinical application. Nanjing First Hospital is committed to improving health outcomes and contributing to the global medical community through rigorous trial design and execution, ensuring the highest standards of ethical practice and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
Lianyungang, Jiangsu, China
Bengbu, Anhui, China
Chuzhou, Anhui, China
Chuzhou, Anhui, China
Changzhou, Jiangsu, China
Huaian, Jiangsu, China
Yixing, Jiangsu, China
Patients applied
Trial Officials
Fei Ye, MD
Principal Investigator
Nanjing First Hospital, Nanjing Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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