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

Coronary Artery Bypass Grafting Surgery Clinical Trial

— ESOS  

Official title:

ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01121341
• Other study ID #: CEI/7
• Status: Recruiting
• Phase: Phase 4
• First received: May 7, 2010
• Last updated: May 19, 2010
• Start date: May 2010

Study information

• Verified date: April 2010
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: Antonio Campanella, MD
• Phone: +39 011 633 55 11
• Email: antoniocampanella[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting Surgery

Intervention

Procedure:
• Vein harvesting
Endoscopic versus conventional vein harvesting

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino	Turin	Piedmont

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista	LivaNova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity hypothesis	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?	six weeks	Yes
Primary	Patient satisfaction hypothesis	· 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	six weeks	Yes
Primary	Resource utilization hypothesis	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	six weeks	Yes
Primary	Quality of vein harvesting hypothesis	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	six weeks	Yes
Secondary	Vein-graft patency hypothesis	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	six weeks	Yes
Secondary	outcome hypothesis	§ 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)	18 months	Yes