Clinical trial NCT03541577: Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement
Official title: Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Lead sponsor: Insight Lifetech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Guangdong Provincial People's Hospital
name: Shenzhen People's Hospital
First posted: 2018-05-30
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease for whom FFR measurement is thought to be clinically indicated.

Brief summary: TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.

Detailed description: Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire.

TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.

Eligibility criteria: General Inclusion Criteria:

* Age: 18-75 years old
* Subjects with coronary artery disease
* Able to understand and provide signed consent

Angiographic Inclusion Criteria:

* Subject has an intermediate stenosis in a native coronary vessel
* The target stenosis has a reference diameter ≥2.50 mm by visual assessment.

Exclusion Criteria:

General Exclusion Criteria:

* Acute ST-elevation or non-ST-elevation myocardial infarction
* Severe heart failure (NYHA≥IV)
* Left ventricular ejection fraction \<30%
* Allergy to adenosine triphosphate (ATP)
* Contraindications for percutaneous coronary intervention (PCI)

Angiographic Exclusion Criteria:

* Target vessel has angiographically visible or suspected thrombus
* Angiographic evidence of a dissection
* Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis

Primary outcomes:
measure: FFR Measurements
timeFrame: Duration of FFR measurement
Secondary outcomes:
measure: Pearson analysis
timeFrame: Duration of FFR measurement
measure: Slope of Passing-Bablok fit
timeFrame: Duration of FFR measurement
measure: Intercept of Passing-Bablok fit
timeFrame: Duration of FFR measurement
measure: Diagnostic FFR concurrence of functionally significant stenosis
timeFrame: Duration of FFR measurement
measure: Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis
timeFrame: Duration of FFR measurement
measure: Device success rate
timeFrame: Duration of FFR measurement
measure: Mean drift
timeFrame: Duration of FFR measurement
measure: Rate of clinically significant drift
timeFrame: Duration of FFR measurement
measure: Rate of device-related adverse effects
timeFrame: Duration of FFR Procedure
measure: PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion
timeFrame: Duration of FFR Procedure
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
Study officials:
References:
citation: Li C, Yang J, Dong S, Dong L, Chen J, Shen L, Zhang F, Li C, Liu H, Hu X, Hau WK, Qian J, Jeremias A, Wang J, Ge J; SUPREME Study Investigators. Multicenter clinical evaluation of a piezoresistive-MEMS-sensor rapid-exchange pressure microcatheter system for fractional flow reserve measurement. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E243-E253. doi: 10.1002/ccd.29678. Epub 2021 May 5.