Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Azienda Socio-Sanitaria Territoriale di Pavia | UNKNOWN |
Not provided
Not provided
The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.
Data collected in this study will be used for technology development, scientific evaluation, education, and regulatory submissions for future products. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in Italy. The product being researched is the Deep Learning-based (DL) algorithm for non-invasive detection of vulnerable coronary plaque.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DL-Based Vulnerable Plaque Detection and Assessment Tool | Enrolled subjects will receive a clinically indicated CCTA and ICA with OCT within 10 days. At least two qualified CCTA radiologists will independently review and annotate the coronary plaques in the CCTA using their local post-processing tools. At least two trained OCT readers will review and annotate the coronary plaques in the ICA/OCT using their local post-processing tools. The original de-identified CCTA data will be inputted into the Vulnerable Plaque Detection and Assessment Tool. The tool will perform the automatic identification of the plaque location and characteristics. These results will be compared to assess the algorithm's performance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Learning-based Vulnerable Plaque Detection and Assessment Tool | Other | Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care. This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool. The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | Number of subjects with raw CCTA and ICA with OCT data | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Tool | Sensitivity, specificity, negative, and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade in comparison to qualified readers | Through study completion, an average of 1 year |
| Safety Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects with chronic coronary syndrome or stable angina, as well as patients with signs of acute coronary syndrome who have been ordered a clinically indicated CCTA and will likely be referred to undergo an ICA combined with OCT will be enrolled in this study. Subjects with recent onset or growing angina may be included in the study. Subjects will be representative of the general population expected to undergo cardiac non-invasive and invasive imaging and treatment procedures as standard of care clinical practice.
The CCTA and ICA with OCT must be carried out within 10 days one from each other. Clinical decision for a PCI after the diagnostic procedures will not limit the enrollment. To preserve the aspect of the plaque, CCTA must be performed first.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Challman | Contact | 8582213007 | melissa.challman@gehealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Deak | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia | Pavia | Lombardy | 27100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of AEs, SAEs, and product issues |
| Through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided