Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements

NCT05417763 | Completed DMC

• 1 other identifier: CTP-01-001
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 11

Brief Summary

TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME study (NCT03541577). This study will further evaluate the safety and efficacy of the physiological indices measured by the TruePhysio pressure microcatheter, including resting and hyperemic indices, with respect to the physiological indices measured by the Pressure Wire.

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia

Keywords

fractional flow reserve; constant-resistance ratio; resting full-cycle ratio

Outcome Measures

Primary Outcomes (1)

• The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia

  Using FFR measured by TruePhysio pressure microcatheter as the reference. The optimal binary cutoff for cRR is determined by using Youden's index.

  Immediate upon completion of the procedure for the last enrolled patient

Secondary Outcomes (25)

• The area under the Receiver Operating Characteristic (ROC) curve (AUC) of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia

  Immediate upon completion of the procedure for the last enrolled patient

• The sensitivity, specificity, positive and negative predictive values of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia

  Immediate upon completion of the procedure for the last enrolled patient

• The AUC of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia

  Immediate upon completion of the procedure for the last enrolled patient

• The overall accuracy, sensitivity, specificity, positive and negative predictive values of cRR in diagnosing myocardial ischemia

  Immediate upon completion of the procedure for the last enrolled patient

• The AUC of RFR measured by the Pressure Wire in diagnosing myocardial ischemia

  Immediate upon completion of the procedure for the last enrolled patient

Study Arms (2)

Pressure Microcatheter-First

Per the result of prior randomization, physiological assessment to the enrolled patient will be performed by the TruePhysio pressure microcatheter system ahead of the Pressure Wire system.

Device: Randomized physiological measurements by the two systems

Pressure Wire-First

Per the result of prior randomization, physiological assessment to the enrolled patient will be performed by the Pressure Wire system ahead of the TruePhysio pressure microcatheter system, per the result of prior randomization.

Device: Randomized physiological measurements by the two systems

Interventions

Randomized physiological measurements by the two systems DEVICE

To measure physiological indices (FFR, cRR and RFR), either pressure microcatheter or pressure wire enters one patient's body. Whether it is the pressure microcatheter or pressure wire firstly to enter is randomized. After completion of one system's physiological assessment, the other system will follow for its physiological assessment.

Pressure Microcatheter-First; Pressure Wire-First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with coronary artery disease.

You may qualify if:

• At least 18 years old;
• Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
• Clinically indicated to physiological assessment.

You may not qualify if:

• Unable to comprehend, or unwilling to sign the informed consent form;
• Contraindicated to the procedures of invasive coronary angiography or percutaneous coronary intervention;
• Clinically diagnosed with severe coronary artery vasospasm;
• Other operator-discerned facts that will make enrollment or the procedure impossible to complete.

Sponsors & Collaborators

• Insight Lifetech Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Peking University Third Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Zunyi Medical College: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (11)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Xiamen Cardiovascular Hospital, Xiamen University

Xiamen, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Location

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: February 28, 2022
• Primary Completion: July 16, 2022
• Study Completion: December 1, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

CN (11)