Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II)

NACompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

August 1, 2018

Primary Completion Date

October 1, 2023

Study Completion Date

October 1, 2023

Conditions
Myocardial Injury
Interventions
OTHER

low temperature rota-flush solution

Patients with severe calcified lesions undergoing RA were performed with low temperature rota-flush solution. The investigators used thermal insulation equipment to keep rota-flush solution at 0~5℃. The EKG and blood pressure were monitored during the RA procedure. After RA, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.

Trial Locations (8)

210006

Nanjing First Hospital, Nanjing

214200

The People's hospital of Yixing, Yixing

221006

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

222061

The First People's Hospital of Lianyungang, Lianyungang

223002

The Second People's Hospital of Huaian, Huaian

233004

The Affiliated Hospital of Bengbu Medical College, Bengbu

239000

The First People's Hospital of Chuzhou, Chuzhou

239400

MingGuang People's Hospital, Chuzhou

All Listed Sponsors
lead

Nanjing First Hospital, Nanjing Medical University

OTHER

NCT03701230 - Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II) | Biotech Hunter | Biotech Hunter