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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Low Temperature Rota-flush Solution for the Treatment of RA-related Myocardial Injury in Patients With Severe Calcified Lesion Undergoing Rotational Atherectomy (RA) (LOTA-II)

Conditions
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Myocardial Injury

Intervention / Treatment
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* Other: low temperature rota-flush solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low temperature rota-flush solution<br>A total of 66 patients are assigned to low temperature rota-flush solution group after randomization schedule. | Other: low temperature rota-flush solution<br>* 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.<br>|
| No Intervention: room temperature rota-flush solution<br>A total of 66 patients are assigned to room temperature rota-flush solution group after randomization schedule. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rate of RA-related myocardial injury in patients with severe calcified lesions 3 days after RA. | the incidence rate of RA-related myocardial injury indicated by the changes in myocardial injury biomarkers (such as TNI and CK-MB) between low temperature rota-flush solution and room temperature rota-flush solution groups in patients with severe calcified lesions 3 days after RA. | 3 days after RA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low temperature, rota-flush solution, RA-related myocardial injury, severe calcified lesion