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| Name | Class |
|---|---|
| Montreal Heart Institute | OTHER |
| Somahlution LLC | INDUSTRY |
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A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.
Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. Imaging, using 64-slice or better MDCT, will be completed 4-6 weeks and 3 months post surgery (CABG) procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOMVC001 Vascular Conduit Solution | Experimental | Each patient will serve as his/her own control because each patient will have two graft segments with one segment immersed in SOMVC001 and the other in heparin dosed saline (Standard solution). Patients will be randomized using a simple random sample allocation scheme. At the time of randomization, patients will be assigned an allocation number. Each randomized patient will be implanted with two SVGs, alternating Target Region A (Circumflex or Diagonal) and Target Region B (Right Coronary System or Diagonal) and alternating (proximal vs. distal) segments of the harvested SV. A randomization schedule will be developed to ensure appropriate randomization allocation of the harvested vein segment being grafted to the targeted regions. |
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| Standard of Care Heparin-dosed saline | Active Comparator | Each patient will serve as his/her own control because each patient will have two graft segments with one segment immersed in SOMVC001 and the other in heparin dosed saline (Standard solution). Patients will be randomized using a simple random sample allocation scheme. At the time of randomization, patients will be assigned an allocation number. Each randomized patient will be implanted with two SVGs, alternating Target Region A (Circumflex or Diagonal) and Target Region B (Right Coronary System or Diagonal) and alternating (proximal vs. distal) segments of the harvested SV. A randomization schedule will be developed to ensure appropriate randomization allocation of the harvested vein segment being grafted to the targeted regions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOMVC001 Vascular Conduit Solution | Device | SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean wall thickness of paired grafts within 100 participants measured at 4-6 weeks and 3 months post-CABG surgery using 64-slice multidetector computed tomography (MDCT) angiography. | 4-6 weeks to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis P Perrault, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29682294 | Derived | Ben Ali W, Voisine P, Olsen PS, Jeanmart H, Noiseux N, Goeken T, Satishchandran V, Cademartiri F, Cutter G, Veerasingam D, Brown C, Emmert MY, Perrault LP. DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial. Open Heart. 2018 Apr 13;5(1):e000780. doi: 10.1136/openhrt-2018-000780. eCollection 2018. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard of care Heparin-dosed saline | Other | SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |