Reconstruction of Diffusely Diseased Left Anterior Descending with Left Internal Mammary Artery On-lay Patch or Saphenous Vein Patch Without Endarterectomy by Opening the Whole Wall of the Diseased Segment(s) Has Less Risk and Fewer Complications Compared to Endarterectomy Technique

February 15, 2025 updated by: Ahmed Ibrahim Gadallah, Assiut University

Different Surgical Strategies for Management of Severely Diseased Left Anterior Descending Artery During Coronary Artery Bypasses Grafting

The objective of this study is to compare different surgical strategies for management of severely diseased LAD artery during CABG i.e. LIMA on-lay patch vs. saphenous vein patch and the distal in situ LIMA and saphenous vein graft (LIMA+ SVG).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Total myocardial revascularization is the primary aim of coronary artery bypass grafting (CABG) . Conventional CABG does not attain sufficient myocardial revascularization in severely diseased left anterior descending coronary artery (LAD). Coronary endarterectomy for severely atherosclerotic LAD was first introduced by Bailey and his coworkers , but it has a higher risk of morality and poor outcomes. The reconstruction of LAD with saphenous vein or left internal mammary artery (LIMA) combined with endarterectomy was described by Fundaro and others surgeons for better long-term patency of LIMA graft and to avoid the drawbacks of endarterectomy. Reconstruction of diffusely diseased LAD with LIMA on-lay patch or saphenous vein patch without endarterectomy by opening the whole wall of the diseased segment(s) has less risk and fewer complications compared to endarterectomy technique. However, the superiority of LIMA path versus saphenous vein patch is still controversial.

In addition, the LIMA patch is occasionally not available as a bypass to LAD, for example with relatively shorter LIMA due to enlarged left ventricle, difficulty in harvesting the proximal LIMA, accidental injury of the LIMA pedicle during harvesting, calcification of the middle or distal LIMA or mismatching between the LAD and distal LIMA. To overcome this, an end-to-end anastomosis with the distal in situ LIMA and saphenous vein graft (SVG) was performed to establish a composite graft to bypass the LAD.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • included patients with long-segment diffusely diseased LAD, with good ejection fraction and elective surgery.

Exclusion Criteria:

  • Patients with associated valve surgery, left ventricular EF less than 40%, and severe comorbidities (renal or liver failure), preoperative dialysis, and hemodynamic instability, emergency operations were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Management of severly diseased LAD
Different surgical strategies for management of severly diseased LAD
Procedure: CABG
CABG
Procedure: LIMA on lay patch
Left internal mammary artery harvesting with on lay patch on left anterior descending coronary artery
Procedure: Safenous vein patch
Safenous vein patch on left anterior descending artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum troponin level
Time Frame: From enrollment to 1 month after intervention
Measure serum troponin level after 48h , after 1 week and after 1 month
From enrollment to 1 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2025

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

January 10, 2027

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Left anterior descending

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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