Comparison of Saphenous Vein Harvesting by Endoscopic Versus Open Conventional Methods

NCT03966222 | Unknown

• 1 other identifier: Sheba-19-6192-ER-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.

Conditions

Coronary Artery Disease

Keywords

Vein graft

Outcome Measures

Primary Outcomes (1)

• Microscopic vein damage by histology examination

  The amount of preserved endothelium and endothelial stretching seen in the histology examination in the two different vein harvesting strategies.

  Immediate

Secondary Outcomes (2)

• Rehospitalization, myocardial infarction and all-cause mortality

  12 months

• New-York Heart Association (NYHA) functional class

  12 months

Study Arms (2)

Open vein harvest

ACTIVE COMPARATOR

For the standard open conventional technique, the saphenous vein will be exposed by a longitudinal leg incision starting from the medial malleolus and ending at the upper medial thigh at the sapheno-femoral junction. The saphenous vein will be dissected free from its perivascular fat pedicle and visible side branches will be ligated and divided.

Other: Open vein harvest

Endoscopic vein harvest

EXPERIMENTAL

We will use the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System for all endoscopic vein extractions, which is an open carbon dioxide (CO2) system. Approximately 6 l/min of CO2 will be continuously insufflated in the subcutaneous tunnel.

Device: Endoscopic vein harvest

Interventions

Endoscopic vein harvest DEVICE

An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision.

Endoscopic vein harvest

Open vein harvest OTHER

Open vein harvest

Open vein harvest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients over the age of 18;
• Patients with ischemic heart disease who are planned to undergo CABG surgery;
• A vein graft in necessary for the revascularization;
• There is no indication for one specific method for vein harvesting;
• Informed consent obtained.

You may not qualify if:

• Patients who undergo a non-elective surgery
• Concomitant procedures during the CABG surgery;
• Any known infection in the past 6 months;
• Evidence of vein thrombosis in an ultrasound study prior to surgery;
• Morbid obesity patients;
• Patients with peripheral vascular disease;
• Patients who would gain from one technique more than the other by any reason (according to the surgeon or investigator opinion);
• Severe primary mitral and aortic valve stenosis or regurgitation;
• Patients who have undergone a previous cardiac surgery from any kind;
• Patients who underwent any surgery in the lower extremities in the past (i.e. orthopedic, vascular, etc.);
• Any serious disease likely to interfere with the conduct of the study;
• Participation in other clinical trial;
• Patients geographically not stable or unavailable for follow-up.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Leonid Sternik, M.D.

  Sheba Medical Center

  STUDY DIRECTOR

Central Study Contacts

Eilon Ram, M.D.

CONTACT

3-5302710; eilon.ram@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized controlled trial.

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 29, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)