Off Pump Coronary Artery Bypass SurgeryLeGooNCT00985634
Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops
A study testing LeGoo in people with Off Pump Coronary Artery Bypass Surgery, run by Pluromed, Inc. at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Off Pump Coronary Artery Bypass Surgery
- What is being tested?
- LeGoo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing elective off pump coronary artery bypass (OPCAB) surgery where the surgeon prospectively plans to use a vascular occlusion device.
- >70% proximal stenosis of at least one target coronary artery, other than left main
- Age: between the ages 18 -79 years
- Gender: male and female
- Subject is willing and able to participate in a clinical research study and provides informed consent.
- Subject is able and willing to participate in required follow-up procedures.
Who cannot join
- Previous cardiac surgery.
- Left ventricular dysfunction (EF <40%)
- >50% of left main coronary artery stenosis
- Subjects with a logistic EuroScore equal to or greater than 10% as calculated by the euroscore.org calculator
- Emergent Surgery: Subjects undergoing surgery before the start of the next working day following catheterization
- Creatinine > 200 µmol/L
Show all 13Show fewer
- Bilirubin > 21 µmol/L
- Subjects with chronic pulmonary disease [ FEV1 < 45% ]
- Any subject who is deemed by the investigator, for any reason, not suitable or able to participate in a clinical research study.
- Pregnant women. Women of childbearing age will require a pregnancy test within 10 days of the operation and will be excluded if the result is positive.
- Women who are lactating.
- Subjects who have undergone other investigational therapy within 30 days prior to the operation or who are scheduled to receive investigational therapy within six months of the operation.
- Subjects suspected to have one intra-myocardial artery among the coronary arteries to be bypassed during that surgery.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik fur Herzchirurgie Herzzentrum Leipzig
Leipzig
Ardawan Rastan, MD, 49 341 865-1421, jwilkie@pluromed.com
Ardawan Rastan, MD
About this study
Official title: Randomized Clinical Evaluation of LeGoo™ Internal Vessel Occluder Vs Traditional Vessel Loops
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.
Read the detailed description
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.
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Being tested
- LeGoo, Control
- Keywords
- off pump bypass OPCAB, OPCAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeGooDevice
LeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon.
ControlDevice
Vessel loops
| Study group | Role | What they receive |
|---|---|---|
| LeGoo | Experimental | Subjects in this arm, which is assigned at random, will receive the study device. Receives: Device: LeGoo |
| Control | Active comparator | Subjects in this arm will not receive the study device, but receive the standard of care for vessel occlusion (vessel loops.) Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: in operating room
Secondary outcomes (2)
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.
Measured: 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.
Measured: one month post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Off Pump Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pluromed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985634
- Sponsor's protocol ID
- LeGoo EURO rev D
- Acronym
- LeGoo
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22115228
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Evaluation of LeGoo™ Internal Vessel Occluder Vs Traditional Vessel Loops
- ClinicalTrials.gov ID
- NCT00985634
- Acronym / sponsor ID
- LeGoo / LeGoo EURO rev D
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Keywords
- off pump bypass OPCAB, OPCAB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Pluromed, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LeGoo | Experimental | Device: LeGooSubjects in this arm, which is assigned at random, will receive the study device. |
| Control | Active comparator | Device: ControlSubjects in this arm will not receive the study device, but receive the standard of care for vessel occlusion (vessel loops.) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects undergoing elective off pump coronary artery bypass (OPCAB) surgery where the surgeon prospectively plans to use a vascular occlusion device.
- >70% proximal stenosis of at least one target coronary artery, other than left main
- Age: between the ages 18 -79 years
- Gender: male and female
- Subject is willing and able to participate in a clinical research study and provides informed consent.
Key exclusion criteria (13 listed)
- Previous cardiac surgery.
- Left ventricular dysfunction (EF <40%)
- >50% of left main coronary artery stenosis
- Subjects with a logistic EuroScore equal to or greater than 10% as calculated by the euroscore.org calculator
- Emergent Surgery: Subjects undergoing surgery before the start of the next working day following catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeGooLeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon. | Device | LeGoo |
| ControlVessel loops | Device | Control |
Primary outcome
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
2 secondary outcomes
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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
- Derived from this study: PubMed 22115228Wimmer-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LeGoo in people with Off Pump Coronary Artery Bypass Surgery, run by Pluromed, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Wilkie, BS (781 932 0574, jwilkie@pluromed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2009.