LAD (Left Anterior Descending) Coronary Artery StenosisNCT06835114
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
A study testing CABG, LIMA on lay patch and Safenous vein patch in people with LAD (Left Anterior Descending) Coronary Artery Stenosis, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- LAD (Left Anterior Descending) Coronary Artery Stenosis
- What is being tested?
- CABG, LIMA on lay patch and Safenous vein patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- included patients with long-segment diffusely diseased LAD, with good ejection fraction and elective surgery.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Being tested
- CABG, LIMA on lay patch, Safenous vein patch
- Medical subject headings
- Leukocyte adhesion deficiency type 1, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
CABG
LIMA on lay patchProcedure or surgery
Left internal mammary artery harvesting with on lay patch on left anterior descending coronary artery
Safenous vein patchProcedure or surgery
Safenous vein patch on left anterior descending artery
| Study group | Role | What they receive |
|---|---|---|
| Management of severly diseased LAD | Experimental | Different surgical strategies for management of severly diseased LAD Receives: Procedure: CABG; Procedure: LIMA on lay patch; Procedure: Safenous vein patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum troponin level
Measure serum troponin level after 48h , after 1 week and after 1 month
Measured: From enrollment to 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start10 Dec 2025 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LAD (Left Anterior Descending) Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Gadallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835114
- Sponsor's protocol ID
- Left anterior descending
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Surgical Strategies for Management of Severely Diseased Left Anterior Descending Artery During Coronary Artery Bypasses Grafting
- ClinicalTrials.gov ID
- NCT06835114
- Acronym / sponsor ID
- Left anterior descending
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management of severly diseased LAD | Experimental | Procedure: CABG, Procedure: LIMA on lay patch, Procedure: Safenous vein patchDifferent surgical strategies for management of severly diseased LAD |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- included patients with long-segment diffusely diseased LAD, with good ejection fraction and elective surgery.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABGCABG | Procedure or surgery | Management of severly diseased LAD |
| LIMA on lay patchLeft internal mammary artery harvesting with on lay patch on left anterior descending coronary artery | Procedure or surgery | Management of severly diseased LAD |
| Safenous vein patchSafenous vein patch on left anterior descending artery | Procedure or surgery | Management of severly diseased LAD |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CABG, LIMA on lay patch and Safenous vein patch in people with LAD (Left Anterior Descending) Coronary Artery Stenosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ibrahim Gadallah (+201067172284, ahmedgadallah629@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum troponin level (time frame: From enrollment to 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.