Clinical trial NCT03701230: Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Injury
Keywords: low temperature
rota-flush solution
RA-related myocardial injury
severe calcified lesion
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence rate of RA-related myocardial injury in patients with severe calcified lesions 3 days after RA.
timeFrame: 3 days after RA
Secondary outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Chuzhou
country: China
facility: The First People's Hospital of Chuzhou
state: Anhui
city: Chuzhou
country: China
facility: MingGuang People's Hospital
state: Anhui
city: Huaian
country: China
facility: The Second People's Hospital of Huaian
state: Jiangsu
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yixing
country: China
facility: The People's hospital of Yixing
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Fei Ye, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.