Coronary Artery Disease
Conditions
Brief summary
Investigational, prospective, multi-site, first in human, feasibility evaluation
Interventions
DEVICESpectraWAVE Imaging System
Coronary imaging
Sponsors
SpectraWAVE, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group 1: Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Patient with an indication for percutaneous coronary intervention (PCI) including: * Angina (stable or unstable), * Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or fractional flow reserve (FFR) ≤0.80 or iFR ≤0.89 must be present), * Non-ST-elevation myocardial infarction (NSTEMI), or * Recent ST-Segment Elevation Myocardial Infarction (STEMI) (\>48 hours from initial presentation and stable). 3. Patients will undergo cardiac catheterization and possible or definite PCI. 4. Signed written informed consent. Angiographic Inclusion Criteria: 1. The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤5.2 mm and diameter stenosis of ≥50% but \<100%. 2. Lesion length \<40 mm.
Exclusion criteria
1. Serum creatinine ≥ 2.5 mg/dL Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine. 2. STEMI within 48 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital. 3. PCI within 24 hours preceding the study procedure. 4. PCI of a lesion within the target vessel within 6 months prior to the study procedure. 5. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including an Intra-Aortic Balloon Pump, at time of procedure. 6. Mobitz II second degree or complete heart block. 7. Unstable ventricular arrhythmias 8. Pulmonary edema (defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (\>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema). 9. Subject is intubated. 10. Left ventricular ejection fraction (LVEF) ≤30% by the most recent imaging test within 3 months prior to procedure. If no LVEF test result within 3 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method. 11. Severe valvular disease (e.g., severe mitral regurgitation or severe aortic stenosis) 12. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past 6 months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.). 13. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used. 14. Presence of 1 or more co-morbidities which reduces life expectancy to less than 6 months or may interfere with protocol study processes. 15. Subject has known hypersensitivity or contraindication to radiocontrast dye that cannot be adequately pre-medicated. 16. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum. 17. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3. 18. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B. 19. Subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past 6 months. 20. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint. 21. Women who are pregnant or breastfeeding 22. Women of childbearing potential unless a pregnancy test is negative within 1 week before study procedure. 23. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or impact the scientific soundness of the clinical investigation results. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Evaluation | From informed consent to hospital discharge after the SpectraWAVE Imaging System procedure, an average of less than one day. | The primary endpoint is the feasibility evaluation of the SpectraWAVE Imaging System to successfully image the native coronary artery as measured by questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | From informed consent to 30-Day Follow-Up Visit after the SpectraWAVE Imaging System procedure. | The secondary endpoint will be the assessment of any adverse events. |
Countries
Colombia
Outcome results
None listed