Myocardial InjuryLOTA-IINCT03701230
Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II)
A study testing low temperature rota-flush solution in people with Myocardial Injury, run by Nanjing First Hospital, Nanjing Medical University at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- low temperature rota-flush solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 8 sitesChina
- Study dates
- 1 Aug 2018to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
The First People's Hospital of Chuzhou
Chuzhou, Anhui, 239000
MingGuang People's Hospital
Chuzhou, Anhui, 239400
The Second People's Hospital of Huaian
Huaian, Jiangsu, 223002
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061
Nanjing First Hospital
Nanjing, Jiangsu, 210006
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
The People's hospital of Yixing
Yixing, Jiangsu, 214200
About this study
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)
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.
Read the detailed 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.
- Conditions
- Myocardial Injury
- Being tested
- low temperature rota-flush solution
- Keywords
- low temperature, rota-flush solution, RA-related myocardial injury, severe calcified lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low temperature rota-flush solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| low temperature rota-flush solution | Experimental | A total of 66 patients are assigned to low temperature rota-flush solution group after randomization schedule. Receives: Other: low temperature rota-flush solution |
| room temperature rota-flush solution | No intervention | A total of 66 patients are assigned to room temperature rota-flush solution group after randomization schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days after RA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Aug 2018
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Ye, MD, Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701230
- Sponsor's protocol ID
- KY20180713-04
- Acronym
- LOTA-II
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16326375Shan 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.
PubMed 28818353McEntegart 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.
PubMed 29741483You W, Wu XQ, Wu ZM, Wang YF, Shen TT, Tang B, Xu T, Ying LH, Pan DF, Yang S, Yin DL, Ye F. 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. Sci Rep. 2025 May 25;15(1):18280. doi: 10.1038/s41598-025-02799-x.
PubMed 40415011
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03701230
- Acronym / sponsor ID
- LOTA-II / KY20180713-04
- Conditions
- Myocardial Injury
- Keywords
- low temperature, rota-flush solution, RA-related myocardial injury, severe calcified lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low temperature rota-flush solution | Experimental | Other: low temperature rota-flush solutionA total of 66 patients are assigned to low temperature rota-flush solution group after randomization schedule. |
| room temperature rota-flush solution | No intervention | –A total of 66 patients are assigned to room temperature rota-flush solution group after randomization schedule. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low temperature rota-flush solutionPatients 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. | Other | low temperature rota-flush solution |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 16326375Mosseri 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.
- Background: PubMed 28818353Shan 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.
- Background: PubMed 29741483McEntegart 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.
- Derived from this study: PubMed 40415011You W, Wu XQ, Wu ZM, Wang YF, Shen TT, Tang B, Xu T, Ying LH, Pan DF, Yang S, Yin DL, Ye F. 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. Sci Rep. 2025 May 25;15(1):18280. doi: 10.1038/s41598-025-02799-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Ye, MD principal investigator
Nanjing First Hospital, Nanjing Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low temperature rota-flush solution in people with Myocardial Injury, run by Nanjing First Hospital, Nanjing Medical University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rate of RA-related myocardial injury in patients with severe calcified lesions 3 days after RA. (time frame: 3 days after RA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701230, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.