Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements (SUPREME II)

Insight Lifetech

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Treatments: Device: Randomized physiological measurements by the two systems

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05417763

CTP-01-001

Details and patient eligibility

About

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.

Full description

This study will evaluate the safety and efficacy of the constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, in both binary and hybrid strategy, with respect to its own fractional flow reserve (FFR) and the FFR or resting full-cycle ratio (RFR) by the Pressure Wire. And the safety and efficacy of the FFR measured by the TruePhysio pressure microcatheter in patients with a border range of diameter stenosis also be validated with respect to the FFR by the Pressure Wire.

The diagnostic accuracy of cRR by the TruePhysio pressure microcatheter system is evaluated, using FFR measured by both systems as reference;

Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire is evaluated, using FFR measured by Pressure Wire as the reference;

The diagnostic accuracy of the hybrid cRR-FFR scheme by the TruePhysio pressure microcatheter is evaluated, using its own FFR as reference;

The diagnostic accuracy of the hybrid RFR-FFR scheme by the Pressure Wire system is evaluated, using its own FFR as reference.

The hybrid scheme for cRR-FFR (pressure microcatheter system), or RFR-FFR (pressure wire system), is defined as following:

• the gray zone is defined as where the sensitivity and specificity are equal, shown as [A, B].

• if cRR or RFR of the target vessel is <A, it is diagnosed as functionally positive in myocardial ischemia;

• if cRR or RFR of the target vessel is >B, it is diagnosed as functionally negative in myocardial ischemia;

• if cRR or RFR of the target vessel is between A and B (including A and B), the diagnostic criterion is superseded by that of FFR, which is:

  • if FFR of the target vessel is > 0.80, it is diagnosed as functionally negative in myocardial ischemia;
  • if FFR of the target vessel is ≤ 0.80, it is diagnosed as functionally positive in myocardial ischemia.

A total of 487 patients are anticipated to be recruited from 11 centers in China.

Enrollment: 487 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

487 participants in 2 patient groups

Pressure Microcatheter-First

Description:

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.

Treatment:

Device: Randomized physiological measurements by the two systems

Pressure Wire-First

Description:

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.

Treatment:

Device: Randomized physiological measurements by the two systems