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

NCT ID: NCT06835114

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2027-01-10

Brief Summary

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).

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.

Conditions

LAD (Left Anterior Descending) Coronary Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Management of severly diseased LAD

Different surgical strategies for management of severly diseased LAD

Group Type: EXPERIMENTAL

CABG

Intervention Type: PROCEDURE

CABG

LIMA on lay patch

Intervention Type: PROCEDURE

Left internal mammary artery harvesting with on lay patch on left anterior descending coronary artery

Safenous vein patch

Intervention Type: PROCEDURE

Safenous vein patch on left anterior descending artery

Interventions

CABG

CABG

Intervention Type: PROCEDURE

LIMA on lay patch

Left internal mammary artery harvesting with on lay patch on left anterior descending coronary artery

Intervention Type: PROCEDURE

Safenous vein patch

Safenous vein patch on left anterior descending artery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ibrahim Gadallah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Ibrahim Gadallah

Role: CONTACT

ahmedgadallah629@gmail.com

+201067172284

Other Identifiers

Left anterior descending

Identifier Type: -

Identifier Source: org_study_id