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| ID | Type | Description | Link |
|---|---|---|---|
| PERSEUS I | Other Grant/Funding Number | Volcano Corporation 120313 |
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| Name | Class |
|---|---|
| Volcano Corporation | INDUSTRY |
| Imperial College London | OTHER |
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Visual assessment of a coronary artery narrowing (called stenosis) seen on angiography is conventionally used to infer how likely the stenosis will limit blood flow (called ischemia) under conditions of increased demand (e.g exercise). This is based on animal work and data from humans with simple single vessel disease with no co-existing conditions. These data have been extrapolated to more complex patients/ complex disease but clearly over-simplifies the situation in the majority of patients cardiologists treat.
Pivotal work by DeBruyne, Pils and colleagues in the 90's convincingly showed that pressure derived measurements, called FFR, from the coronary artery during a cardiac catheterization, more accurately identify stenoses that would cause ischemia compared to visual assessment alone. A strategy of FFR guided coronary stenting with drug eluting stents significantly improved outcomes and reduced costs compared to visual assessment alone (FAME trial). Deferring treatment based on FFR has been shown to be safe (DEFER Trial). FFR has excellent sensitivity and specificity. A FFR of <=0.80 was used as this identified ischemia causing lesions 90% of the time. Therefore, the concept of FFR guided percutaneous revascularisation and treatment deferral has a robust evidence base to support it.
Coronary bypass grafting (CABG) is traditionally based solely on a visual assessment of angiography images. SPY® Infrared Fluorescence Angiography (NIRF, FDA approved 2005) is used by some cardiac surgeons to assess the patency of bypass grafts in real-time in the operating room, as a surrogate for immediate traditional coronary angiography. Dr. Ferguson observed that regional myocardial perfusion (RMP) image data was also captured in these video sequences.
Study Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients referred for CABG | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ComboMap XT Guidewire | Device | Intracoronary pressure and flow measurements |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Analysis | Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow | 18 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation Analysis | Correlation analysis between anatomy, functional anatomy, FFR, CFR, HMR and SPY® perfusion data for each TVECA and perfusion territory. | 18 months |
| Instantaneous Wave Free Ratio (iFR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashesh N Buch, MBChB, MD | East Carolina University | Principal Investigator |
| T. Bruce Ferguson, MD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina Heart Institute at Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2023 | |
| Reset | Feb 22, 2024 | |
| Release | Mar 26, 2024 | |
| Reset | Aug 29, 2024 | |
| Release | Sep 26, 2024 | |
| Reset | Nov 21, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2023 | Feb 22, 2024 | |||
| Mar 26, 2024 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Controlled prospective observational study
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| 'SPY' NIRF During CABG |
| Procedure |
FDA approved use of injection of indocyanine green for the purposes of performing pre and post coronary grafting graft patency and perfusion assessment with the SPY near infra red fluorescence system |
|
Offline analysis of de-identified encrypted data for each TVECA interrogated with ComboMap XT wire by Dr Justin Davies's research group, Imperial College, London for iFR determination. Correlation analysis between iFR and presence or absence of imaged competitive flow and intra-operative RMP data on SPY® NIRF
| 18 months |
| Wave Intensity Analysis (WIA) | Offline wave wave intensity analysis (WIA) of de-identified encrypted data for each TVECA interrogated with ComboMap XT wire by Dr Justin Davies's research group, Imperial College, London. Correlation analysis between WIA data and presence or absence of imaged competitive flow and intra-operative RMP data on SPY® NIRF | 18 months |
| Aug 29, 2024 |
| Sep 26, 2024 | Nov 21, 2024 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |