Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II) (LOTA-II)
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| ClinicalTrials.gov Identifier: NCT03701230 |
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Recruitment Status :
Recruiting
First Posted : October 9, 2018
Last Update Posted : September 5, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Injury | Other: low temperature rota-flush solution | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | August 1, 2018 |
| Estimated Primary Completion Date : | December 1, 2021 |
| Estimated Study Completion Date : | December 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: low temperature rota-flush solution
A total of 55 patients are assigned to low temperature rota-flush solution group after randomization schedule.
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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. |
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No Intervention: room temperature rota-flush solution
A total of 55 patients are assigned to room temperature rota-flush solution group after randomization schedule.
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- the incidence rate of RA-related myocardial injury in patients with severe calcified lesions 3 days after RA. [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701230
| Contact: Fei Ye, MD | +86 13327823900 | doctor_ye@126.com | |
| Contact: Xiangqi Wu, MD | +86 15250997876 | 15250997876@163.com |
| China, Anhui | |
| The Affiliated Hospital of Bengbu Medical College | Recruiting |
| Bengbu, Anhui, China, 233004 | |
| Contact: Heng Zhang, MD +8613965270077 13965270077@139.com | |
| Contact: Yao Chen, MD +8613855286301 chenyao_841206@126.com | |
| The First People's Hospital of Chuzhou | Recruiting |
| Chuzhou, Anhui, China, 239000 | |
| Contact: Limin Zhou, MD +8613705503905 zhlm0902@sina.com | |
| Contact: Tongtong Shen, MD +8613955016856 37024942@qq.com | |
| MingGuang People's Hospital | Recruiting |
| Chuzhou, Anhui, China, 239400 | |
| Contact: Xianglian Ma +8613515505166 mxl0102@qq.com | |
| China, Jiangsu | |
| The First People's Hospital of Changzhou | Recruiting |
| Changzhou, Jiangsu, China, 213000 | |
| Contact: Haiyan Ke, MD +8613511670112 khyrain2014@163.com | |
| Contact: Jin Zhu, MD +8613813598210 zhujin8011@163.com | |
| The Second People's Hospital of Huaian | Recruiting |
| Huaian, Jiangsu, China, 223002 | |
| Contact: Yuansheng Zhu, MD +8613953397479 hazys0517@163.com | |
| Contact: Shu Guan, MD +8615189609559 guanshu6408@163.com | |
| The First People's Hospital of Lianyungang | Recruiting |
| Lianyungang, Jiangsu, China, 222061 | |
| Contact: Delu Yin, MD +8618961326475 druseyin@163.com | |
| Contact: Qunxing Li, MD +8618961321567 759045538@qq.com | |
| Nanjing First Hospital | Recruiting |
| Nanjing, Jiangsu, China, 210006 | |
| Contact: Fei Ye, MD +86 13327823900 doctor_ye@126.com | |
| Contact: Xiangqi Wu, MD +86 15250997876 15250997876@163.com | |
| The Affiliated Hospital of Xuzhou Medical University | Recruiting |
| Xuzhou, Jiangsu, China, 221006 | |
| Contact: Defeng Pan, MD +8613852438611 1320120945@qq.com | |
| Contact: Jie Liu, MD +8615252148972 515967514@qq.com | |
| The People's hospital of Yixing | Recruiting |
| Yixing, Jiangsu, China, 214200 | |
| Contact: Song Yang, MD +8618601569266 staff052@yxph.com | |
| Contact: Liang Xu, MD +8618861576565 staff1015@yxph.com | |
| Principal Investigator: | Fei Ye, MD | Nanjing First Hospital, Nanjing Medical University |
| Responsible Party: | Nanjing First Hospital, Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT03701230 |
| Other Study ID Numbers: |
KY20180713-04 |
| First Posted: | October 9, 2018 Key Record Dates |
| Last Update Posted: | September 5, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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low temperature rota-flush solution RA-related myocardial injury severe calcified lesion |
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Wounds and Injuries |