The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-12-31

Brief Summary

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This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Novasight IVUS/OCT

A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter

Group Type EXPERIMENTAL

Intravascular imaging

Intervention Type DIAGNOSTIC_TEST

Use of imaging catheter

Interventions

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Intravascular imaging

Use of imaging catheter

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Subject must be at least 18 years of age and less than 85 years of age.
2. Subject must be informed and sign a written consent
3. Subject must have evidence of myocardial ischemia, unstable angina or acute myocardial infarction suitable for PCI.

Exclusion Criteria

1. Women who are pregnant or cannot eliminate the possibility to be pregnant.
2. Estimated creatinine clearance \<30 ml/min/1.73 m2 using Cockcroft equation.
3. LVEF(Left ventricular ejection fraction) \< 35% by the most recent imaging test within 7 days prior to procedure.
4. Unstable ventricular arrhythmias.
5. High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months.
6. Known contraindication to anticoagulants and antiplatelets therapy.
7. Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent.
8. Any intervention for not target vessel within 48 hours after the study procedure.
9. Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation.

1. The reference diameter of target vessel is less than 2.5 mm.
2. The target lesion involves myocardial bridge.
3. The target lesion is in the left main coronary artery or the damage is observed in the ostium.
4. Severe calcification in the target vessel.
5. Severe tortuosity in the target vessel.
6. Multiple contiguous stent implantation in the target vessel.
7. Subject has coronary artery spasm.
8. In-stent restenosis.
9. Any study lesion characteristic that, in the investigator's opinion, is not available for intravascular imaging.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No