Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)

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

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-08-18

Brief Summary

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Collection of coronary images with a hybrid IVUS OCT system.

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Detailed Description

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A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.

Conditions

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Stable Angina Acute Coronary Syndrome

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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Observation group

Patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.

Group Type OTHER

Observation group

Intervention Type DEVICE

Collect coronary images with a hybrid IVUS OCT system.

Interventions

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Observation group

Collect coronary images with a hybrid IVUS OCT system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient is at least 18 years old.
2. Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
3. Patients with STEMI may be undergoing subsequent staged PCI to additional coronary stenoses after the index STEMI event has been successful treated with primary PCI.
4. Vascular access of at least 6F.
5. Patient provides informed, written consent for participation in the study.
6. A target lesion is present in a suitable artery for intravascular imaging.

Exclusion Criteria

1. Angiographic evidence of severe calcification
2. Marked tortuosity that precludes imaging of a target coronary artery.
3. GFR (Glomerular filtration rate) \<35 mL/min.
4. Patients in cardiogenic shock.
5. Women of child bearing potential, in whom pregnancy cannot be excluded.
6. Patients of age \< 18 years old.
7. Patients with an allergy to contrast.
8. Patients unable to grant informed, written consent for participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No