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

NCT03701230 | Completed

• 1 other identifier: KY20180713-04
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Myocardial Injury

Keywords

low temperature; rota-flush solution; RA-related myocardial injury; severe calcified lesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

low temperature rota-flush solution

EXPERIMENTAL

A total of 66 patients are assigned to low temperature rota-flush solution group after randomization schedule.

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.

Interventions

low temperature rota-flush solution OTHER

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.

low temperature rota-flush solution

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (8)

The Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

The First People's Hospital of Chuzhou

Chuzhou, Anhui, 239000, China

Location

MingGuang People's Hospital

Chuzhou, Anhui, 239400, China

Location

The Second People's Hospital of Huaian

Huaian, Jiangsu, 223002, China

Location

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222061, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

The People's hospital of Yixing

Yixing, Jiangsu, 214200, China

Location

Related Publications (4)

• 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.

  PMID: 16326375 BACKGROUND

• 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.

  PMID: 28818353 BACKGROUND

• 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.

  PMID: 29741483 BACKGROUND

• You 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.

  PMID: 40415011 DERIVED

Study Officials

• Fei Ye, MD

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 9, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)