NCT00985634

Brief 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 LeGoo™ in off-pump coronary bypass (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

September 24, 2009

Last Update Submit

September 25, 2009

Conditions

Off Pump Coronary Artery Bypass Surgery

Keywords

off pump bypass OPCABOPCAB

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

    one month post op

Study Arms (2)

LeGoo

EXPERIMENTAL

Subjects in this arm, which is assigned at random, will receive the study device.

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.)

Device: Control

Interventions

LeGooDEVICE

LeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon.

LeGoo
ControlDEVICE

Vessel loops

Control

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik fur Herzchirurgie Herzzentrum Leipzig

Leipzig, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22115228DERIVED

Central Study Contacts

James A Wilkie, BS

CONTACT

781 932 0574jwilkie@pluromed.com

Jean-Marie Vogel, BS

CONTACT

781 932 0574jvogel@pluromed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 28, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

DE(1)