Coronary Artery DiseaseNCT05933473
Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Assiut University.
Trial summary
Prospective interventional study evaluating clinical and procedural outcomes of patients with ostial left anterior descending artery lesion PCI alone or crossover with left main artery Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with Significant ostial LAD >50% stenosis within 5mm from ostium
- Either CCS (ongoing symptoms despite medical therapy) or ACS patients.
- De-novo lesions.
Who cannot join
- Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial LCX greater than 50%).
- Patients with protected LM.
- In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.
Trial locations and contacts
No sites are listed yet.
About this study
Prospective interventional study evaluating clinical and procedural outcomes of patients with ostial left anterior descending artery lesion PCI alone or crossover with left main artery
Read the detailed description
Aim of the work:
- Evaluate the clinical and procedural outcomes in patients undergoing percutaneous intervention (PCI) for ostial left anterior descending (LAD) lesions while comparing the outcomes between those treated with a stent crossing over (CO) to the left main (LM) versus ostial stenting (OS) alone.
- Define predictors of success in Ostial LAD lesion PCI.
Patients and methods:
1)Patients:
Inclusion criteria:
- Patients with Significant ostial LAD >50% stenosis within 5mm from ostium
- Either chronic coronary syndrome (CCS) (ongoing symptoms despite medical therapy) or acute coronary syndrome (ACS) patients.
- De-novo lesions.
Exclusion Criteria:
- Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial left circumflex (LCX) greater than 50%).
- Patients with protected LM.
- In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.
Methods:
It is prospective cohort study on patients in Assiut university heart hospital catheterization lab. with ostial LAD lesion (median, 0.1.0) that will include baseline demographic, clinical, and angiographic data.
All patients will be thoroughly informed about the procedure's possible risks and benefits, as well as alternative therapeutic choices prior to the intervention, and obtained signed consent from all participants.
In all cases, percutaneous coronary interventions and stenting will be performed according to standard techniques either trans-radial or transfemoral approach.
All patients pre-treated with dual antiplatelet therapy, including aspirin and loading dose of either clopidogrel or ticagrelor.
Unfractionated heparin will be given to all patients during the procedure with a target activated clotting time of >250 seconds.
Two main strategies for treating ostial LAD lesions will be used and analyzed in this study:
- Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed.
- Ostial stenting of the LAD (OS) with no crossover back to the LM. The choice of the technique and the use of intravascular imaging (IVUS) depends on the discretion of the treating interventional cardiologist.
- Patients included in our study will be subjected to:
- Detailed History.
- General and complete cardiac examination.
- 12-Leads ECG.
- Detailed Echocardiography. \ 5)Coronary angiography findings including:
- Quantitative angiographic measurements:
- Reference diameter (mm).
- Diameter stenosis (%).
- Lesion length and distance from LAD ostium(mm).
- Medina classification.
- Bifurcation angle.
- Techniques used:
- Ostial LAD stenting.
- Crossover with LM. C. IVUS or angiography guided PCI.
Basic IVUS Measurement
The following basic measurements may be made with IVUS:
- Minimum lumen diameter (MLD): the shortest diameter via lumen's center.
- Minimum lumen area (MLA): the smallest area via the lumen's center.
- Stenosis area: (reference lumen area - stenosis lumen area)/reference lumen area.
- Plaque burden: (EEM area - lumen area) / EEM area .
- Contrast volume (ml) E. Fluoroscopy time (min.) Data will be gathered during hospital admission and follow-up. In-hospital mortality and morbidity will be documented.
Follow up:
During the hospital admission:
Both techniques used by our operators in these cases will be overviewed and evaluated as regarding:
- Angiographic success in target vessel defined as (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch (SB) angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3).
- Procedural Success A successful PCI should achieve angiographic success without in-hospital major clinical complications (e.g., cardiac death, target vessel related MI, emergency coronary artery bypass surgery) during hospitalization
- Clinical Success in the short term, a clinically successful PCI includes anatomic and procedural success with relief of signs and/or symptoms of myocardial ischemia after the patient recovers from the procedure.
Information about the in-hospital outcome will be obtained from an electronic clinical database for patients maintained at our institution and by review of hospital records for those discharged to referring hospitals.
Short term follow up (after 6 months):
- Per our institutional protocol, clinical follow-up will be performed by physicians in outpatient clinic after 4 months.
- Control coronary angiography will be scheduled at 6 months to all cases.
- Information on the occurrence of cardiac death, target vessel related myocardial infarction or repeated revascularization during period of follow-up will be collected by consulting our institutional electronic database and by contacting referring physicians and institutions and all living patients.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
percutaneous intervention to oseal LAD with or without LM stenting
| Study group | Role | What they receive |
|---|---|---|
| LM-LAD (Crossover stenting (CO)) | Active comparator | Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed. Receives: Procedure: Percutaneous coronary intervention |
| ostial LAD (Ostial stenting(OS)) | Active comparator | Ostial stenting of the LAD (OS) with no cross-over back to the LM. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical outcomes using different techniques in ostial LAD
Evaluate the clinical outcomes in patients undergoing PCI for ostial LAD lesions
The primary end points are:
-Target vessel related myocardial infarction occuring within 48 hours defined by absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus 1 (or more) of the following criteria:
- Flow-limiting angiographic complications.
- New "substantial" loss of myocardium on imaging.
Measured: 6 months
Secondary outcomes (3)
Predictors of PCI success
-Angiographic success in target vessel defined as residual stenosis ≤ 30% and TIMI flow grade 3
Measured: 6 months
Predictors of PCI success
-Angiographic success in target vessel defined as SB angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3).
Measured: 6 months
Predictors of ostial LAD PCI success
-Procedural Success by doing successful PCI without in-hospital major clinical complications wihin one week of hospitalizaion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MA Abdelreheem, Assiut University
- Investigators
- Mohamed AN AbdEl-Reheem, MSC, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933473
- Sponsor's protocol ID
- Coronary interventions
- Status last verified
- Jun 2023
- First submitted
- 7 Apr 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
PubMed 29891620Rigatelli G, Zuin M, Baracca E, Galasso P, Carraro M, Mazza A, Lanza D, Roncon L, Daggubati R. Long-Term Clinical Outcomes of Isolated Ostial Left Anterior Descending Disease Treatment: Ostial Stenting Versus Left Main Cross-Over Stenting. Cardiovasc Revasc Med. 2019 Dec;20(12):1058-1062. doi: 10.1016/j.carrev.2019.01.030. Epub 2019 Jan 31.
PubMed 30797760Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol. 1993 Dec;22(7):2033-54. No abstract available.
PubMed 8245363Frangos C, Noble S, Piazza N, Asgar A, Fortier A, Ly QH, Bonan R. Impact of bifurcation lesions on angiographic characteristics and procedural success in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Arch Cardiovasc Dis. 2011 Apr;104(4):234-41. doi: 10.1016/j.acvd.2011.02.001. Epub 2011 Apr 19.
PubMed 21624790
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main
- ClinicalTrials.gov ID
- NCT05933473
- Acronym / sponsor ID
- Coronary interventions
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 6 Jul 2023 (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.
Prospective interventional study evaluating clinical and procedural outcomes of patients with ostial left anterior descending artery lesion PCI alone or crossover with left main artery
Detailed description
Aim of the work:
- Evaluate the clinical and procedural outcomes in patients undergoing percutaneous intervention (PCI) for ostial left anterior descending (LAD) lesions while comparing the outcomes between those treated with a stent crossing over (CO) to the left main (LM) versus ostial stenting (OS) alone.
- Define predictors of success in Ostial LAD lesion PCI.
Patients and methods:
1)Patients:
Inclusion criteria:
- Patients with Significant ostial LAD >50% stenosis within 5mm from ostium
- Either chronic coronary syndrome (CCS) (ongoing symptoms despite medical therapy) or acute coronary syndrome (ACS) patients.
- De-novo lesions.
Exclusion Criteria:
- Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial left circumflex (LCX) greater than 50%).
- Patients with protected LM.
- In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.
Methods:
It is prospective cohort study on patients in Assiut university heart hospital catheterization lab. with ostial LAD lesion (median, 0.1.0) that will include baseline demographic, clinical, and angiographic data.
All patients will be thoroughly informed about the procedure's possible risks and benefits, as well as alternative therapeutic choices prior to the intervention, and obtained signed consent from all participants.
In all cases, percutaneous coronary interventions and stenting will be performed according to standard techniques either trans-radial or transfemoral approach.
All patients pre-treated with dual antiplatelet therapy, including aspirin and loading dose of either clopidogrel or ticagrelor.
Unfractionated heparin will be given to all patients during the procedure with a target activated clotting time of >250 seconds.
Two main strategies for treating ostial LAD lesions will be used and analyzed in this study:
- Crossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed.
- Ostial stenting of the LAD (OS) with no crossover back to the LM. The choice of the technique and the use of intravascular imaging (IVUS) depends on the discretion of the treating interventional cardiologist.
- Patients included in our study will be subjected to:
- Detailed History.
- General and complete cardiac examination.
- 12-Leads ECG.
- Detailed Echocardiography. \ 5)Coronary angiography findings including:
- Quantitative angiographic measurements:
- Reference diameter (mm).
- Diameter stenosis (%).
- Lesion length and distance from LAD ostium(mm).
- Medina classification.
- Bifurcation angle.
- Techniques used:
- Ostial LAD stenting.
- Crossover with LM. C. IVUS or angiography guided PCI.
Basic IVUS Measurement
The following basic measurements may be made with IVUS:
- Minimum lumen diameter (MLD): the shortest diameter via lumen's center.
- Minimum lumen area (MLA): the smallest area via the lumen's center.
- Stenosis area: (reference lumen area - stenosis lumen area)/reference lumen area.
- Plaque burden: (EEM area - lumen area) / EEM area .
- Contrast volume (ml) E. Fluoroscopy time (min.) Data will be gathered during hospital admission and follow-up. In-hospital mortality and morbidity will be documented.
Follow up:
During the hospital admission:
Both techniques used by our operators in these cases will be overviewed and evaluated as regarding:
- Angiographic success in target vessel defined as (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch (SB) angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3).
- Procedural Success A successful PCI should achieve angiographic success without in-hospital major clinical complications (e.g., cardiac death, target vessel related MI, emergency coronary artery bypass surgery) during hospitalization
- Clinical Success in the short term, a clinically successful PCI includes anatomic and procedural success with relief of signs and/or symptoms of myocardial ischemia after the patient recovers from the procedure.
Information about the in-hospital outcome will be obtained from an electronic clinical database for patients maintained at our institution and by review of hospital records for those discharged to referring hospitals.
Short term follow up (after 6 months):
- Per our institutional protocol, clinical follow-up will be performed by physicians in outpatient clinic after 4 months.
- Control coronary angiography will be scheduled at 6 months to all cases.
- Information on the occurrence of cardiac death, target vessel related myocardial infarction or repeated revascularization during period of follow-up will be collected by consulting our institutional electronic database and by contacting referring physicians and institutions and all living patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-LAD (Crossover stenting (CO)) | Active comparator | Procedure: Percutaneous coronary interventionCrossover stenting (CO) from the LM into the LAD, using standard provisional bifurcation techniques and proximal stent optimization (POT), where post dilatation was typically performed. |
| ostial LAD (Ostial stenting(OS)) | Active comparator | Procedure: Percutaneous coronary interventionOstial stenting of the LAD (OS) with no cross-over back to the LM. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Significant ostial LAD >50% stenosis within 5mm from ostium
- Either CCS (ongoing symptoms despite medical therapy) or ACS patients.
- De-novo lesions.
Key exclusion criteria (3 listed)
- Those with coronary angiography results such as: (significant disease of the LM more than 40% or ostial LCX greater than 50%).
- Patients with protected LM.
- In adherence to a dual antiplatelet regimen by enrolled patients within the first 12 months after the procedure.
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 |
|---|---|---|
| Percutaneous coronary interventionpercutaneous intervention to oseal LAD with or without LM stenting | Procedure or surgery | LM-LAD (Crossover stenting (CO)), ostial LAD (Ostial stenting(OS)) |
Primary outcome
Evaluation of the clinical outcomes using different techniques in ostial LAD
Time frame: 6 months
Evaluate the clinical outcomes in patients undergoing PCI for ostial LAD lesions The primary end points are: -Target vessel related myocardial infarction occuring within 48 hours defined by absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus 1 (or more) of the following criteria: * Flow-limiting angiographic complications. * New "substantial" loss of myocardium on imaging.
3 secondary outcomes
Predictors of PCI success
Time frame: 6 months
Predictors of PCI success
Time frame: 6 months
Predictors of ostial LAD PCI success
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 29891620Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Background: PubMed 30797760Rigatelli G, Zuin M, Baracca E, Galasso P, Carraro M, Mazza A, Lanza D, Roncon L, Daggubati R. Long-Term Clinical Outcomes of Isolated Ostial Left Anterior Descending Disease Treatment: Ostial Stenting Versus Left Main Cross-Over Stenting. Cardiovasc Revasc Med. 2019 Dec;20(12):1058-1062. doi: 10.1016/j.carrev.2019.01.030. Epub 2019 Jan 31.
- Background: PubMed 8245363Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol. 1993 Dec;22(7):2033-54. No abstract available.
- Background: PubMed 21624790Frangos C, Noble S, Piazza N, Asgar A, Fortier A, Ly QH, Bonan R. Impact of bifurcation lesions on angiographic characteristics and procedural success in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Arch Cardiovasc Dis. 2011 Apr;104(4):234-41. doi: 10.1016/j.acvd.2011.02.001. Epub 2011 Apr 19.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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. This study is not recruiting at the moment.
Mohamed AN AbdEl-Reheem, MSC principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed AN AbdEl-Reheem, MSC (01119535430, m.naserdrea3@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the clinical outcomes using different techniques in ostial LAD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933473, which also lists 4 linked publications.
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 6 Jul 2023.