Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2025-12-16 @ 11:18 PM
Study NCT ID:
NCT05872074
Status:
None
Last Update Posted:
2023-05-24 00:00:00
First Post:
2023-04-14 00:00:00
Brief Title:
Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions
Status:
None
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCB
Brief Summary:
Study Design:
A prospective study. Patients who met the inclusion criteria will be enrolled in our study will be subdivided into 2 groups :-
Group A: patient Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty Group B: patient Who will undergo provisional stenting using Drug coated balloon The patients will be randomly assigned for each group using a computer randomizing software application.
Both group with pass 3 stages: - Pre-procedural Interventional procedure Post -procedural Pre- procedural
History taking:
Age \& sex. Family history. Smoking status. Medical history including hypertension (HTN), diabetes mellitus (DM), renal impairment, etc.
Previous history of coronary artery disease, myocardial infarctions (MI), revascularization procedures Medical treatment and any significant history of allergy Previous intervention history regarding (site, type, diameter and length of the stent , complications and TIMI flow ) if available
General \&Physical examination:
with special emphasis on vital data, decubitus ,lung osculation and peripheral pulsation
Laboratory investigations:
Including kidney function, complete blood count, and High sensitive troponin in case of acute coronary syndrome Echocardiography will be done routinely for all patients with special emphasis on ejection fraction (to be assessed by modified Simpson's method), left ventricular dimensions, resting segmental wall motion abnormalities (RSWMAs).
Interventional procedure. Angiographic analysis. Serial coronary angiography will be performed at baseline (before and after intervention) and angiograms will be obtained in multiple views after intra-coronary nitrate if coronary spasm is suspected. coronary angiograms will be digitally recorded and analyzed by experienced personnel using a validated offline quantitative angiographic system and the following data will be collected: -
Bifurcation lesion distribution:
Left main artery bifurcation Left anterior descending artery/diagonal bifurcation Left circumflex artery/obtuse marginal bifurcation Right coronary artery/posterolateral branch
Medina classification the investigators will use Medina classification for coronary bifurcation lesion in which recording any narrowing more than 50% in each of the three arterial segments of the bifurcation in the following order: proximal main vessel (PMV). Distal main branch (DMV). Side branch (SB)
(1) is used to indicate the presence of a significant stenosis and (0) the absence of stenosis
Main vessel
Proximal reference diameter (mm) Distal reference diameter (mm) Mean reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%)) Lesion length (mm) Angiographic restenosis (%)
Side branch
Reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%) Lesion length (mm)
Type of drug-eluting stents Sirolimus-eluting stents Everolimus-eluting stents Zotrolimus-eluting stents Biolimus A9-eluting stent Number of stent/drug-eluting balloon used Stent/drug-eluting balloon size (mm) Stent/drug-eluting balloon length (mm) Maximum balloon size (mm) Maximum inflation pressure (atmosphere) other coronary lesions
Intervention
1. wire both branches, MV and SB, with two coronary guide wires.
2. Main branch pre-dilation
3. Side branch pre-dilation using (ordinary balloon in group "A" and Drug coated balloon in group "B" for the side branch)
4. Main vessel stenting
5. Proximal optimization technique (POT) of the main vessel stent
The following data will be recorded: -
1. Inflation time (Seconds.)
2. Inflation pressure (atmospheric pressure.)
3. Diameter of the stent after inflation
4. Time of the procedure After Intervention
1\) Reference luminal diameter (mm) 2) Minimal luminal diameter in stent (mm) 3) Minimal luminal diameter in lesion (mm) 4) lesion success (attainment of \>50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis) 5) procedure success (attainment of a final lesion success and no major angiographic complications as dissection or perforation ).
Post-procedural Medications will be prescribed according to 2018 ESC myocardial revascularization guidelines.
Patients will be assessed for immediate outcomes:
lesion success attainment of \>50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis procedure success attainment of a final lesion success and no major complication as :-
A. Perforation with or without tamponade B. vascular access complications C. myocardial infarction D. contrast-induced nephropathy E. urgent coronary artery bypass grafting F. urgent repeat PCI G. Death.
Patients be assessed and monitor for 24 hours after the procedure and in the outpatient clinic after 6 months.
Follow up clinically after 6 months for MACEs
Study end points. Primary end point target is 6-month follow-up for:-
MACEs (major adverse cardiac events) defined as :-
1. Death
2. Non-fatal myocardial infarction
3. Target lesion re-vascularization (TLR) "defined as any clinically driven intervention (surgical or percutaneous) to the target lesion or any segment of the epicardial coronary artery containing the target lesion"
4. Stroke
Improvement or recurrence of symptoms (chest pain and dyspnea) Symptomatic patients will undergo coronary angiography and those who has no symptoms with undergo functional assessment using either (High dose dobutamine echo or Myocardial perfusion imaging )
Secondary end points included:
lesion success procedure success
A prospective study. Patients who met the inclusion criteria will be enrolled in our study will be subdivided into 2 groups :-
Group A: patient Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty Group B: patient Who will undergo provisional stenting using Drug coated balloon The patients will be randomly assigned for each group using a computer randomizing software application.
Both group with pass 3 stages: - Pre-procedural Interventional procedure Post -procedural Pre- procedural
History taking:
Age \& sex. Family history. Smoking status. Medical history including hypertension (HTN), diabetes mellitus (DM), renal impairment, etc.
Previous history of coronary artery disease, myocardial infarctions (MI), revascularization procedures Medical treatment and any significant history of allergy Previous intervention history regarding (site, type, diameter and length of the stent , complications and TIMI flow ) if available
General \&Physical examination:
with special emphasis on vital data, decubitus ,lung osculation and peripheral pulsation
Laboratory investigations:
Including kidney function, complete blood count, and High sensitive troponin in case of acute coronary syndrome Echocardiography will be done routinely for all patients with special emphasis on ejection fraction (to be assessed by modified Simpson's method), left ventricular dimensions, resting segmental wall motion abnormalities (RSWMAs).
Interventional procedure. Angiographic analysis. Serial coronary angiography will be performed at baseline (before and after intervention) and angiograms will be obtained in multiple views after intra-coronary nitrate if coronary spasm is suspected. coronary angiograms will be digitally recorded and analyzed by experienced personnel using a validated offline quantitative angiographic system and the following data will be collected: -
Bifurcation lesion distribution:
Left main artery bifurcation Left anterior descending artery/diagonal bifurcation Left circumflex artery/obtuse marginal bifurcation Right coronary artery/posterolateral branch
Medina classification the investigators will use Medina classification for coronary bifurcation lesion in which recording any narrowing more than 50% in each of the three arterial segments of the bifurcation in the following order: proximal main vessel (PMV). Distal main branch (DMV). Side branch (SB)
(1) is used to indicate the presence of a significant stenosis and (0) the absence of stenosis
Main vessel
Proximal reference diameter (mm) Distal reference diameter (mm) Mean reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%)) Lesion length (mm) Angiographic restenosis (%)
Side branch
Reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%) Lesion length (mm)
Type of drug-eluting stents Sirolimus-eluting stents Everolimus-eluting stents Zotrolimus-eluting stents Biolimus A9-eluting stent Number of stent/drug-eluting balloon used Stent/drug-eluting balloon size (mm) Stent/drug-eluting balloon length (mm) Maximum balloon size (mm) Maximum inflation pressure (atmosphere) other coronary lesions
Intervention
1. wire both branches, MV and SB, with two coronary guide wires.
2. Main branch pre-dilation
3. Side branch pre-dilation using (ordinary balloon in group "A" and Drug coated balloon in group "B" for the side branch)
4. Main vessel stenting
5. Proximal optimization technique (POT) of the main vessel stent
The following data will be recorded: -
1. Inflation time (Seconds.)
2. Inflation pressure (atmospheric pressure.)
3. Diameter of the stent after inflation
4. Time of the procedure After Intervention
1\) Reference luminal diameter (mm) 2) Minimal luminal diameter in stent (mm) 3) Minimal luminal diameter in lesion (mm) 4) lesion success (attainment of \>50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis) 5) procedure success (attainment of a final lesion success and no major angiographic complications as dissection or perforation ).
Post-procedural Medications will be prescribed according to 2018 ESC myocardial revascularization guidelines.
Patients will be assessed for immediate outcomes:
lesion success attainment of \>50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis procedure success attainment of a final lesion success and no major complication as :-
A. Perforation with or without tamponade B. vascular access complications C. myocardial infarction D. contrast-induced nephropathy E. urgent coronary artery bypass grafting F. urgent repeat PCI G. Death.
Patients be assessed and monitor for 24 hours after the procedure and in the outpatient clinic after 6 months.
Follow up clinically after 6 months for MACEs
Study end points. Primary end point target is 6-month follow-up for:-
MACEs (major adverse cardiac events) defined as :-
1. Death
2. Non-fatal myocardial infarction
3. Target lesion re-vascularization (TLR) "defined as any clinically driven intervention (surgical or percutaneous) to the target lesion or any segment of the epicardial coronary artery containing the target lesion"
4. Stroke
Improvement or recurrence of symptoms (chest pain and dyspnea) Symptomatic patients will undergo coronary angiography and those who has no symptoms with undergo functional assessment using either (High dose dobutamine echo or Myocardial perfusion imaging )
Secondary end points included:
lesion success procedure success
Detailed Description:
Study Design
A prospective study Patients who met the inclusion criteria will be enrolled in our study will be subdivided into 2 groups -
Group A patient Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty Group B patient Who will undergo provisional stenting using Drug coated balloon The patients will be randomly assigned for each group using a computer randomizing software application
Both group with pass 3 stages - Pre-procedural Interventional procedure Post -procedural Pre- procedural
History taking
Age sex Family history Smoking status Medical history including hypertension HTN diabetes mellitus DM renal impairment etc
Previous history of coronary artery disease myocardial infarctions MI revascularization procedures Medical treatment and any significant history of allergy Previous intervention history regarding site type diameter and length of the stent complications and TIMI flow if available
General Physical examination
with special emphasis on vital data decubitus lung osculation and peripheral pulsation
Laboratory investigations
Including kidney function complete blood count and High sensitive troponin in case of acute coronary syndrome Echocardiography will be done routinely for all patients with special emphasis on ejection fraction to be assessed by modified Simpsons method left ventricular dimensions resting segmental wall motion abnormalities RSWMAs
Interventional procedure Angiographic analysis Serial coronary angiography will be performed at baseline before and after intervention and angiograms will be obtained in multiple views after intra-coronary nitrate if coronary spasm is suspected coronary angiograms will be digitally recorded and analyzed by experienced personnel using a validated offline quantitative angiographic system and the following data will be collected -
Bifurcation lesion distribution
Left main artery bifurcation Left anterior descending arterydiagonal bifurcation Left circumflex arteryobtuse marginal bifurcation Right coronary arteryposterolateral branch
Medina classification the investigators will use Medina classification for coronary bifurcation lesion in which recording any narrowing more than 50 in each of the three arterial segments of the bifurcation in the following order proximal main vessel PMV Distal main branch DMV Side branch SB
1 is used to indicate the presence of a significant stenosis and 0 the absence of stenosis
Main vessel
Proximal reference diameter mm Distal reference diameter mm Mean reference diameter mm Minimal lumen diameter mm Percentage diameter stenosis Lesion length mm Angiographic restenosis
Side branch
Reference diameter mm Minimal lumen diameter mm Percentage diameter stenosis Lesion length mm
Type of drug-eluting stents Sirolimus-eluting stents Everolimus-eluting stents Zotrolimus-eluting stents Biolimus A9-eluting stent Number of stentdrug-eluting balloon used Stentdrug-eluting balloon size mm Stentdrug-eluting balloon length mm Maximum balloon size mm Maximum inflation pressure atmosphere other coronary lesions
Intervention
1 wire both branches MV and SB with two coronary guide wires
2 Main branch pre-dilation
3 Side branch pre-dilation using ordinary balloon in group A and Drug coated balloon in group B for the side branch
4 Main vessel stenting
5 Proximal optimization technique POT of the main vessel stent
The following data will be recorded -
1 Inflation time Seconds
2 Inflation pressure atmospheric pressure
3 Diameter of the stent after inflation
4 Time of the procedure After Intervention
1 Reference luminal diameter mm 2 Minimal luminal diameter in stent mm 3 Minimal luminal diameter in lesion mm 4 lesion success attainment of 50 residual stenosis of the target lesion as measured by quantitative coronary angiographic analysis 5 procedure success attainment of a final lesion success and no major angiographic complications as dissection or perforation
Post-procedural Medications will be prescribed according to 2018 ESC myocardial revascularization guidelines
Patients will be assessed for immediate outcomes
lesion success attainment of 50 residual stenosis of the target lesion as measured by quantitative coronary angiographic analysis procedure success attainment of a final lesion success and no major complication as -
A Perforation with or without tamponade B vascular access complications C myocardial infarction D contrast-induced nephropathy E urgent coronary artery bypass grafting F urgent repeat PCI G Death
Patients be assessed and monitor for 24 hours after the procedure and in the outpatient clinic after 6 months
Follow up clinically after 6 months for MACEs
Study end points Primary end point target is 6-month follow-up for-
MACEs major adverse cardiac events defined as -
1 Death
2 Non-fatal myocardial infarction
3 Target lesion re-vascularization TLR defined as any clinically driven intervention surgical or percutaneous to the target lesion or any segment of the epicardial coronary artery containing the target lesion
4 Stroke
Improvement or recurrence of symptoms chest pain and dyspnea Symptomatic patients will undergo coronary angiography and those who has no symptoms with undergo functional assessment using either High dose dobutamine echo or Myocardial perfusion imaging
Secondary end points included
lesion success procedure success
A prospective study Patients who met the inclusion criteria will be enrolled in our study will be subdivided into 2 groups -
Group A patient Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty Group B patient Who will undergo provisional stenting using Drug coated balloon The patients will be randomly assigned for each group using a computer randomizing software application
Both group with pass 3 stages - Pre-procedural Interventional procedure Post -procedural Pre- procedural
History taking
Age sex Family history Smoking status Medical history including hypertension HTN diabetes mellitus DM renal impairment etc
Previous history of coronary artery disease myocardial infarctions MI revascularization procedures Medical treatment and any significant history of allergy Previous intervention history regarding site type diameter and length of the stent complications and TIMI flow if available
General Physical examination
with special emphasis on vital data decubitus lung osculation and peripheral pulsation
Laboratory investigations
Including kidney function complete blood count and High sensitive troponin in case of acute coronary syndrome Echocardiography will be done routinely for all patients with special emphasis on ejection fraction to be assessed by modified Simpsons method left ventricular dimensions resting segmental wall motion abnormalities RSWMAs
Interventional procedure Angiographic analysis Serial coronary angiography will be performed at baseline before and after intervention and angiograms will be obtained in multiple views after intra-coronary nitrate if coronary spasm is suspected coronary angiograms will be digitally recorded and analyzed by experienced personnel using a validated offline quantitative angiographic system and the following data will be collected -
Bifurcation lesion distribution
Left main artery bifurcation Left anterior descending arterydiagonal bifurcation Left circumflex arteryobtuse marginal bifurcation Right coronary arteryposterolateral branch
Medina classification the investigators will use Medina classification for coronary bifurcation lesion in which recording any narrowing more than 50 in each of the three arterial segments of the bifurcation in the following order proximal main vessel PMV Distal main branch DMV Side branch SB
1 is used to indicate the presence of a significant stenosis and 0 the absence of stenosis
Main vessel
Proximal reference diameter mm Distal reference diameter mm Mean reference diameter mm Minimal lumen diameter mm Percentage diameter stenosis Lesion length mm Angiographic restenosis
Side branch
Reference diameter mm Minimal lumen diameter mm Percentage diameter stenosis Lesion length mm
Type of drug-eluting stents Sirolimus-eluting stents Everolimus-eluting stents Zotrolimus-eluting stents Biolimus A9-eluting stent Number of stentdrug-eluting balloon used Stentdrug-eluting balloon size mm Stentdrug-eluting balloon length mm Maximum balloon size mm Maximum inflation pressure atmosphere other coronary lesions
Intervention
1 wire both branches MV and SB with two coronary guide wires
2 Main branch pre-dilation
3 Side branch pre-dilation using ordinary balloon in group A and Drug coated balloon in group B for the side branch
4 Main vessel stenting
5 Proximal optimization technique POT of the main vessel stent
The following data will be recorded -
1 Inflation time Seconds
2 Inflation pressure atmospheric pressure
3 Diameter of the stent after inflation
4 Time of the procedure After Intervention
1 Reference luminal diameter mm 2 Minimal luminal diameter in stent mm 3 Minimal luminal diameter in lesion mm 4 lesion success attainment of 50 residual stenosis of the target lesion as measured by quantitative coronary angiographic analysis 5 procedure success attainment of a final lesion success and no major angiographic complications as dissection or perforation
Post-procedural Medications will be prescribed according to 2018 ESC myocardial revascularization guidelines
Patients will be assessed for immediate outcomes
lesion success attainment of 50 residual stenosis of the target lesion as measured by quantitative coronary angiographic analysis procedure success attainment of a final lesion success and no major complication as -
A Perforation with or without tamponade B vascular access complications C myocardial infarction D contrast-induced nephropathy E urgent coronary artery bypass grafting F urgent repeat PCI G Death
Patients be assessed and monitor for 24 hours after the procedure and in the outpatient clinic after 6 months
Follow up clinically after 6 months for MACEs
Study end points Primary end point target is 6-month follow-up for-
MACEs major adverse cardiac events defined as -
1 Death
2 Non-fatal myocardial infarction
3 Target lesion re-vascularization TLR defined as any clinically driven intervention surgical or percutaneous to the target lesion or any segment of the epicardial coronary artery containing the target lesion
4 Stroke
Improvement or recurrence of symptoms chest pain and dyspnea Symptomatic patients will undergo coronary angiography and those who has no symptoms with undergo functional assessment using either High dose dobutamine echo or Myocardial perfusion imaging
Secondary end points included
lesion success procedure success
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None