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The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGooâ„¢ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGooâ„¢ is suitable for use in any vascular surgery where temporary vessel occlusion is desired, this study specifically focuses on the use of LeGooâ„¢ in off-pump coronary bypass (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.
The purpose of this study is to evaluate the clinical efficacy of LeGooâ„¢ as compared to a traditional vessel loop. LeGoo is a device that is intended to be used during surgical procedures to temporarily occlude blood vessels while forming an anastomosis. LeGooâ„¢ will be evaluated in subjects undergoing off-pump coronary artery by-pass (OPCAB) surgery. This is a prospective, randomized trial with a 30-day follow-up period. Half of the eligible patients will be randomized to the experimental group (LeGooâ„¢); and the other half to the control group (standard vessel loops).
LeGooâ„¢ is polymer-based device which is comprised of a non-toxic and biocompatible gel that exists as a liquid at low temperatures and rapidly transitions to a solid at body temperature, forming a plug that can occlude blood vessels. LeGooâ„¢ is injected into a blood vessel that is intended to be occluded, where it stays in a "plug" form for several minutes allowing the surgeon to work in a bloodless field. The gel dissolves with time (spontaneously) or can be reversed back to liquid instantly by cooling the site with ice or irrigating with cold saline. Once dissolved below a minimum concentration, the polymer can never re-solidify.
The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGooâ„¢ than using a conventional temporary hemostasis technique.
Satisfactory hemostasis is defined by the surgeon who will quantitate his/her observation about the quality of the surgical field using the following scoring system:
"Excellent hemostasis" and "minimal bleeding" are considered "satisfactory hemostasis." Satisfactory hemostasis will constitute a treatment success for the purpose of evaluating the primary efficacy of LeGoo. The primary endpoint is the proportion of anastomoses in which satisfactory hemostasis is achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LeGoo | Experimental | Subjects in this arm, which is assigned at random, will receive the study device. |
|
| Control | Active Comparator | Subjects in this arm will not receive the study device, but receive the standard of care for vessel occlusion (vessel loops.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LeGoo | Device | LeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGooâ„¢ than using a conventional temporary hemostasis technique. | in operating room |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of the anastomosis, blood loss during the surgery, Time required to occlude the vessel, the number of units of blood transfused during hospitalization. | in operating room (day of surgery) | |
| Safety will be measured by comparing a composite of four serious adverse events experienced by the treated and control groups: death, graft occlusion, myocardial damage, and low post procedure cardiac output. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James A Wilkie, BS | Contact | 781 932 0574 | jwilkie@pluromed.com | |
| Jean-Marie Vogel, BS | Contact | 781 932 0574 | jvogel@pluromed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik fur Herzchirurgie Herzzentrum Leipzig | Recruiting | Leipzig | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115228 | Derived | Wimmer-Greinecker G, Bouchot O, Verhoye JP, Perrault LP, Borgermann J, Diegeler A, Van Garsse L, Rastan AJ. Randomized clinical trial comparing a thermosensitive polymer (LeGoo) with conventional vessel loops for temporary coronary artery occlusion during off-pump coronary artery bypass surgery. Ann Thorac Surg. 2011 Dec;92(6):2177-83. doi: 10.1016/j.athoracsur.2011.07.003. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 29, 2011 | |
| Reset | Aug 29, 2011 | |
| Release | Oct 10, 2012 | |
| Reset | Nov 8, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 29, 2011 | Aug 29, 2011 | |||
| Oct 10, 2012 |
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| Control | Device | Vessel loops |
|
| one month post op |
| Nov 8, 2012 |