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

Myocardial Injury Clinical Trial

— LOTA-II  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701230
• Other study ID #: KY20180713-04
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	MingGuang People's Hospital	Chuzhou	Anhui
China	The First People's Hospital of Chuzhou	Chuzhou	Anhui
China	The Second People's Hospital of Huaian	Huaian	Jiangsu
China	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	The People's hospital of Yixing	Yixing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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