Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops
Recruitment status was Recruiting
The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGoo™ is suitable for use in any vascular surgery where temporary vessel occlusion is desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Evaluation of LeGoo™ Internal Vessel Occluder Vs Traditional Vessel Loops|
- The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique. [ Time Frame: in operating room ] [ Designated as safety issue: No ]
- 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. [ Time Frame: in operating room (day of surgery) ] [ Designated as safety issue: No ]
- 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. [ Time Frame: one month post op ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Subjects in this arm, which is assigned at random, will receive the study device.
LeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon.
Active Comparator: Control
Subjects in this arm will not receive the study device, but receive the standard of care for vessel occlusion (vessel loops.)
The purpose of this study is to evaluate the clinical efficacy of LeGoo™ 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. LeGoo™ 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 (LeGoo™); and the other half to the control group (standard vessel loops).
LeGoo™ 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. LeGoo™ 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 LeGoo™ 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 (no bleeding)
- - Minimal bleeding (bleeding does not interfere with suturing)
- - Modest bleeding (required intermittent use of another device to control bleeding at the site of the anastomosis)
- - Copious bleeding (required continuous use of another device)
"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.
|Contact: James A Wilkie, BS||781 932 email@example.com|
|Contact: Jean-Marie Vogel, BS||781 932 firstname.lastname@example.org|
|Klinik fur Herzchirurgie Herzzentrum Leipzig||Recruiting|
|Contact: Ardawan Rastan, MD 49 341 865-1421 email@example.com|
|Principal Investigator: Ardawan Rastan, MD|