- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03701230
Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II) (LOTA-II)
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Anhui
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Bengbu, Anhui, China, 233004
- The Affiliated Hospital of Bengbu Medical College
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Chuzhou, Anhui, China, 239000
- The First People's Hospital of Chuzhou
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Chuzhou, Anhui, China, 239400
- MingGuang People's Hospital
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Jiangsu
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Huaian, Jiangsu, China, 223002
- The second people's hospital of Huaian
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Lianyungang, Jiangsu, China, 222061
- The First People's Hospital of Lianyungang
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Nanjing, Jiangsu, China, 210006
- Nanjing First Hospital
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Xuzhou, Jiangsu, China, 221006
- The Affiliated Hospital of Xuzhou Medical University
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Yixing, Jiangsu, China, 214200
- The People's hospital of Yixing
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low temperature rota-flush solution
A total of 66 patients are assigned to low temperature rota-flush solution group after randomization schedule.
|
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 66 patients are assigned to room temperature rota-flush solution group after randomization schedule.
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What is the study measuring?
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.
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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3 days after RA
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fei Ye, MD, Nanjing First Hospital, Nanjing Medical University
Publications and helpful links
General Publications
- Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005 Oct-Dec;6(4):147-53. doi: 10.1016/j.carrev.2005.08.008.
- Shan P, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Genereux P, Crowley A, Kirtane AJ, Stone GW, Maehara A. Does calcium burden impact culprit lesion morphology and clinical results? An ADAPT-DES IVUS substudy. Int J Cardiol. 2017 Dec 1;248:97-102. doi: 10.1016/j.ijcard.2017.08.028. Epub 2017 Aug 12.
- McEntegart M, Corcoran D, Carrick D, Clerfond G, Sidik N, Collison D, Robertson KR, Shaukat A, Watkins S, Rocchicholi PR, Eteiba H, Petrie MP, Lindsay MM, Oldroyd KG, Berry C. Incidence of procedural myocardial infarction and cardiac magnetic resonance imaging-detected myocardial injury following percutaneous coronary intervention with rotational atherectomy. EuroIntervention. 2018 Sep 20;14(7):819-823. doi: 10.4244/EIJ-D-17-01077. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20180713-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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