ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sorin Group
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT01121341
First received: May 7, 2010
Last updated: May 19, 2010
Last verified: April 2010
  Purpose

The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.


Condition Intervention Phase
Coronary Artery Bypass Grafting Surgery
Procedure: Vein harvesting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • Morbidity hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

    When compared to Conventional vein-graft harvesting (CVH) in CABG surgery

    · Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?


  • Patient satisfaction hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

    · Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D?

    • To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat
    • To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes

  • Resource utilization hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

    When compared to Conventional vein-graft harvesting (CVH) in CABG surgery

    · Does EVOH affect resource utilization?

    • Harvesting time related to the length of vein segments
    • Harvesting closure time
    • CABG time
    • Mobility time
    • Hospital length of stay
    • Re-exploration for bleeding due to vein-graft bleed
    • Readmission for leg wound complications
    • Need for outpatient wound management resources
    • To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat

  • Quality of vein harvesting hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

    When compared to Conventional vein-graft harvesting (CVH) in CABG surgery

    • Do EVOH compromises the quality of venous conduit harvested?

      • Number of harvested veins requiring repair
      • Number of repairs to each vein
      • Re-exploration for bleeding due to vein-graft bleed
      • Histological integrity
    • Specific secondary subanalysis adjusted for:

      • Preparation solution of the vein conduit

        • 20 ml autologous blood
        • 0,5 ml heparin (5000UI/ml) = 2500 UI
        • 2 ml papavarine (30mg/ml) = 60 mg
      • Uncontrolled distension pressure/ no touch technique harvesting


Secondary Outcome Measures:
  • Vein-graft patency hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

    Does EVH Open-CO2 system influence and improve vein-graft patency?

    • Assessment of systemic carbon dioxide absorption with respiratory and hemodynamic parameters
    • Assessment of vein-graft patency with:

      • vein conduit quality [diameter/well thickness]
      • vein segments above/below the knee
      • target coronary artery grafted territory
      • target coronary artery diameter
      • target coronary artery stenosis
      • target coronary artery severity disease
      • ascending aorta disease
      • composite /uncomposite graft
      • left ventricular function

  • outcome hypothesis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

    § Detection of long-term outcomes:

    • MACE (major adverse cardiac events): death; myocardial infarction; revascularization (PCI or CABG) for ischemia or angina recurrence
    • MACE related to vein-graft failure
    • GF (vein-graft failure): at least 75% of stenosis;
    • GO (vein-graft occlusion) at angiographic study
    • to identify factors in addition to treatment assignment that are associated with variations in long-term outcomes and graft patency
    • baseline demographic characteristics and medications used of two treatment arms (EVOH/CVH)


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVOH
Procedure: Endoscopic vein with an open CO2 system harvesting
Procedure: Vein harvesting
Endoscopic versus conventional vein harvesting
Active Comparator: OVH
Procedure: Conventional vein harvesting
Procedure: Vein harvesting
Endoscopic versus conventional vein harvesting

Detailed Description:

The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective planned CABG surgery
  • First isolated CABG surgery

Exclusion Criteria:

  • Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support
  • Previous cardiac surgery
  • Planned concomitant valve surgery
  • Very varicous veins
  • Previous saphenectomy
  • History of deep vein thrombosis
  • History of suffered trauma on the lower extremity
  • Preoperative legs immobilization
  • Previous leg wound complications
  • Coexisting illness with life expectancy < five years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121341

Contacts
Contact: Antonio Campanella, MD +39 011 633 55 11 antoniocampanella@libero.it

Locations
Italy
Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino Recruiting
Turin, Piedmont, Italy, 10126
Contact: Antonio Campanella, MD    +39 011 633 55 11    antoniocampanella@libero.it   
Sub-Investigator: Antonio Campanella, MD         
Principal Investigator: Mauro Rinaldi, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Sorin Group
Investigators
Study Chair: Antonio Campanella, MD Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
Principal Investigator: Mauro Rinaldi, MD, PhD Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
  More Information

No publications provided by Azienda Ospedaliera San Giovanni Battista

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Silvana Barbaro and Serenella Scipioni, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier: NCT01121341     History of Changes
Other Study ID Numbers: CEI/7
Study First Received: May 7, 2010
Last Updated: May 19, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
Endoscopic vein harvesting
Saphenous vein
Conventional vein harvesting

ClinicalTrials.gov processed this record on August 28, 2014