Status:
COMPLETED
Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)
Lead Sponsor:
Conavi
Conditions:
Stable Angina
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Collection of coronary images with a hybrid IVUS OCT system.
Detailed 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 an...
Eligibility Criteria
Inclusion
- Patient is at least 18 years old.
- Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
- 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.
- Vascular access of at least 6F.
- Patient provides informed, written consent for participation in the study.
- A target lesion is present in a suitable artery for intravascular imaging.
Exclusion
- Angiographic evidence of severe calcification
- Marked tortuosity that precludes imaging of a target coronary artery.
- GFR (Glomerular filtration rate) \<35 mL/min.
- Patients in cardiogenic shock.
- Women of child bearing potential, in whom pregnancy cannot be excluded.
- Patients of age \< 18 years old.
- Patients with an allergy to contrast.
- Patients unable to grant informed, written consent for participation in the study.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03484975
Start Date
August 1 2018
End Date
August 18 2021
Last Update
August 31 2021
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2