NCT03701230: LOTA-II

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

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing low temperature rota-flush solution in Myocardial Injury in 132 participants. Completed in 1 October 2023.

Timeline

1 August 2018

Primary endpoint
1 October 2023

1 October 2023

Quick facts

Lead sponsor	Nanjing First Hospital, Nanjing Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	132
Start date	1 August 2018
Primary completion	1 October 2023
Estimated completion	1 October 2023
Sites	8 locations across China

Drugs / interventions tested

• low temperature rota-flush solution

Conditions studied

• Myocardial Injury — all drugs for Myocardial Injury →

Sponsor

Nanjing First Hospital, Nanjing Medical University

Who can join

Adults 18 to 100, any sex, with Myocardial Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Calcified lesions related to coronary artery are a type of atherosclerosis, accompanied by severe calcified lesions of the stenosis, which is a difficult point for PCI interventional therapy. Calcified lesions have poor response to balloon dilatation and the device can not be successfully placed, which reduce the success rate of operation. Furthermore, the stent is under-expanded and the adherence is poor, which significantly increases the incidence of major adverse cardiovascular events (MACEs).

Intracoronary rotational atherectomy (RA) was developed by David Auth in the early 1980s. In 1988, Bertrand has completed the first case of coronary RA. RA was recommended for treatment of severe calcified lesions in ACC/AHA Guidelines for Coronary Interventional Therapy in 2011 (IIa, C). However, many studies have found that the incidence of RA-related myocardial injury is relatively high, and affect the efficacy of RA and prognosis in patients with severe calcified lesions. It has been reported that 58 consecutive patients with stable angina requiring PCI with RA to a calcified coronary lesion have 68% 5-fold increase in high sensitivity troponin after RA. The objective of this randomized control trial is to gain a clinical insight on the use of low temperature rota-flush solution for the treatment of RA-related myocardial injury in patients with heavy calcified lesions. The primary objective is assess efficacy and safety of low temperature rota-flush solution for the treatment of RA-related myocardial injury in patients with severe calcified lesions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and efficacy of low-temperature RA-flush solution in patients with moderate-to-severe calcified lesions (LOTA-II): a randomized, double-blind, multicenter study.
   You W, Wu XQ, Wu ZM, Wang YF, et al · · 2025 · cited 1× · PMID 40415011 · DOI 10.1038/s41598-025-02799-x