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

Nanjing Medical University

Status: Completed

Conditions: Myocardial Injury

Treatments: Other: low temperature rota-flush solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03701230

KY20180713-04

Details and patient eligibility

About

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.

Full description

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 calcified lesions undergoing PCI after treatment with low temperature rota-flush solution. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 132 patients with heavy calcified lesions were required, and with 66 patients per group as a ratio of 1:1 randomization.

Enrollment: 132 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

low temperature rota-flush solution

Experimental group

Description:

A total of 66 patients are assigned to low temperature rota-flush solution group after randomization schedule.

Treatment:

Other: low temperature rota-flush solution

room temperature rota-flush solution

No Intervention group

Description:

A total of 66 patients are assigned to room temperature rota-flush solution group after randomization schedule.