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

Conavi

Status: Completed

Conditions: Acute Coronary Syndrome; Stable Angina

Treatments: Device: Observation group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03484975

EXT-020

Details and patient eligibility

About

Collection of coronary images with a hybrid IVUS OCT system.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Observation group

Other group

Description:

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.

Treatment:

Device: Observation group