Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177808
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-11-12
Brief Title:
Assessment of Cutting-Balloon Angioplasty With Everolimus-Eluting StentEES in the Treatment of Coronary Calcified LesionCCL Guided by Intravascular UltrasonographyIVUS
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
Assessment of Cutting-Balloon Angioplasty With Novel Bioabsorbable Polymer-Coated Everolimus-Eluting Stent in the Treatment of Calcified Coronary Lesions Guided by Intravascular Ultrasound
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
None
Brief Summary:
The study seeks to address the clinical question of how effectively a novel cutting balloon Wolverine can modify calcified lesions for stent implantation in comparison with a non-compliant NC balloon particularly when used alongside a bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy
Most previous researches on cutting balloons focused on only severe calcifications and had limitations such as small sample sizes with retrospective designs emphasizing on short-term imaging outcomes This study differs by including mild to severe calcifications and evaluating long-term clinical outcomes intraprocedural factors and operator convenience It aims to provide evidence that could potentially expand the indications for cutting balloon use and inform insurance coverage policies
The objective of the study is to test the safety and efficacy of the cutting balloon in preparing calcified coronary lesions for stent insertion compared to conventional methods
Most previous researches on cutting balloons focused on only severe calcifications and had limitations such as small sample sizes with retrospective designs emphasizing on short-term imaging outcomes This study differs by including mild to severe calcifications and evaluating long-term clinical outcomes intraprocedural factors and operator convenience It aims to provide evidence that could potentially expand the indications for cutting balloon use and inform insurance coverage policies
The objective of the study is to test the safety and efficacy of the cutting balloon in preparing calcified coronary lesions for stent insertion compared to conventional methods
Detailed Description:
1 Background
1 Which clinical question shall be answered Heavily calcified lesions respond poorly to conventional balloon angioplasty when stents are implanted in incompletely modified lesions resulting in incomplete and asymmetrical stent expansion Inadequate calcium and plaque modification is related to worse clinical outcomes In addition incomplete modification and preparation of calcified lesions adversely affect the number of balloons amount of contrast procedure time and stent delivery failure Periprocedural factors such as the amount of contrast medium and procedure time are also known to be related to adverse clinical outcomes and in-hospital complication rates Various devices such as cutting balloons spiral balloons and rotational atherectomy devices have been used to modify calcium lesions The cutting balloon has four blades surrounding the balloon When the balloon is inflated the blades initiate a score into the plaque after which the shear force applied by the balloon inflation propagates the crack and results in lumen enlargement However evidence related to use of the cutting balloon for various degrees of calcified lesions is limited In addition despite the advantages of the cutting balloon in the treatment of calcium lesions investigations designed to focus on intraprocedural and operator-oriented endpoints such as the number of balloons used procedure time and the total amount of contrast medium used are also rare Moreover bioabsorbable polymer-coated coronary stents have proven to be safe and effective for the treatment of coronary artery diseases including calcified lesions Therefore in this study the investigators aim to evaluate the safety and efficacy including intraprocedural and operator-oriented outcomes of a novel cutting balloon Wolverine Boston Scientific Natick MassachusettsMA USA compared with a non-compliant NC balloon in the treatment of patients with various degrees of calcified lesions including mild to heavily calcified lesions who are treated with intravascular ultrasound IVUS guided bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy Boston Scientific Corporation Marlborough MA USA implantation
2 To what degree has this question already been investigated elsewhere What are the differentiators to already published studies The Wolverine balloon Boston Scientific Corporation is a novel cutting balloon mounted on a semi-compliant balloon with three or four arthrotomies bonded longitudinally to its surface Some studies on the use of cutting balloons in the treatment of coronary arteries have been previously reported but most of them investigated moderately or severely calcified lesions compared with NC balloons Another limitation of previous studies is that they included a small number of patients and had a retrospective design In addition previous studies have mainly focused on periprocedural outcomes based on imaging studies such as acute luminal gain and cross-sectional areaCSA using IVUS
In this study the indication of a cutting balloon is not limited to severe calcified coronary artery disease but expanded to mild calcified coronary artery disease including in-stent restenosisISR to achieve optimal preconditioning for stent implantation through active calcium modification Apart from the acute phase per-procedural gain of calcium modification the investigators aim to investigate the long-term endpoints such as major adverse cardiac eventsMACE with aggressive calcium modification and an appropriate type of drug-eluting stent implantation This trial is to be conducted using a bioabsorbable polymer-coated drug-eluting coronary stent The SYNERGY stent Boston Scientific Corporation Marlborough MA USA is a thin strut 74 μm of platinum-chromium metal alloy that elutes everolimus from an ultrathin 4 μm bioabsorbable polymer applied only to the abluminal surface of the stent and resolves within 4 months After the absorption period of the polymer only ultrathin 70 or 80 μm stent struts remain and ultrathin stent struts improve clinical outcomes in the treatment of various coronary artery diseases
Previously a few studies have reported the stent crossability of novel cutting balloons for treating calcium lesions However studies focusing on intraprocedural operator-centric factors such as the procedure time amount of contrast medium and number of balloons used are lacking As previously reported periprocedural and intraprocedural factors such as the amount of contrast medium and procedure time are also related to adverse clinical outcomes in the complex percutaneous coronary interventionPCI era As Effect of cutting balloon after rotational atherectomy in severely calcified coronary artery lesions as assessed by optical coherence tomography reported the low crossability of the old model cutting balloon makes the operator hesitant to choose a cutting balloon as a first-line option in the treatment of the calcified lesion However the crossability of the novel cutting balloon Wolverine was improved and proved to have a higher delivery success rate caused by the induction of superior crossability derived from active calcium modification In addition owing to the development of balloon platform technologies there have been reports on the improvement of stent and balloon crossability in the treatment of calcium lesions with novel cutting balloons compared with old cutting or scoring balloons In our study the investigators additionally focus on intraprocedural and operator-centric outcomes and the total procedure time number of balloons and amount of contrast medium used are set as the parameters of the secondary endpoints
In conclusion this study evaluates the efficacy and safety of the novel cutting balloon Wolverine compared to the NC balloon in treating patients with calcified coronary lesions undergoing PCI It aims to provide insights into the optimal type of balloons for modifying calcium lesions Additionally the study seeks to broaden the application of the cutting balloon exploring its use in a range of coronary calcified lesions from mild to severe This comparative approach extends to assessing clinical benefits including intraprocedural and periprocedural outcomes as well as factors like the total number of balloons used procedure time and contrast amount for enhanced operator convenience Furthermore the study intends to demonstrate the mid- to long-term clinical advantages of using cutting balloons for aggressive modification of calcified lesions followed by the implantation of bioabsorbable polymer-coated everolimus-eluting coronary stents Synergy Boston Scientific Corporation Marlborough MA USA Lastly given the limited insurance coverage for cutting balloons in some countries this research also aims to substantiate their use in treating mild stenosis and ISR lesions potentially influencing broader insurance policy inclusion
3 Can this question only be answered by a clinical investigation Although the use of a cutting balloon in the treatment of heavy calcified lesions has been previously proven the investigators believe that clinical studies are needed to demonstrate the effectiveness of treatment of various calcium lesions including restenosis through this study In addition since it is a study that requires results through imaging tests and long-term clinical observation it is necessary to conduct clinical research As the basis for the safety of cutting balloons has been sufficiently proven in previous clinical studies it is considered that there are no ethical problems
4 Why and for whom is it important to perform this study The investigators evaluate the efficacy and safety of the novel cutting balloon Wolverine in patients with calcified coronary lesions undergoing PCI and will provide rationale for which type of balloons will optimally modify the calcium lesions In addition the investigators attempt to expand the indications of the cutting balloon for the treatment of mild to severe coronary calcified lesions by conducting a comparative study of the NC and cutting balloons in the treatment of calcified lesions
The investigators aim to investigate the clinical benefits of intraprocedural and periprocedural outcomes and operator convenience such as the number of total balloons used procedure time and amount of contrast The scope of insurance coverage for cutting balloons remains limited in some countries therefore this study aims to provide evidence for extending insurance coverage to the treatment of mild stenosis and ISR lesions
5 What and how will Boston Scientific technology be used The following devices will be used 1 Wolverine Boston Scientific Natick MA USA cutting balloon 2 bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy Boston Scientific Corporation Marlborough MA USA and 3 NC balloon the type of NC balloon will be decided at the operators discretion
PCI and stent implantation will be performed according to the current guidelines using standard interventional techniques The interventional strategy balloon size and stent selection will be based on the discretion of the same operator for all patients Modification of the atheroma using rota-ablation will be performed at the operators discretion in cases of balloon-uncrossable lesions and these cases will be excluded from enrollment After pre-dilation all patients would be treated with bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy Boston Scientific Corporation Marlborough MA USA After regular coronary angiography IVUS will be performed at baseline before pre-dilatation and repeated immediately after stent implantation in all cases IVUS will be performed using an OptiCross 60 MHz Scientific Corporation Maple Grove MinnesotaMN USA After intracoronary injection of nitroglycerin the IVUS catheter will be carefully advanced distal to the culprit lesion under fluoroscopic guidance and then withdrawn automatically at 05 mms to perform the imaging sequence which begins 20 mm distal to the culprit lesion and ends at the aorto-ostial junction
6 Is the device approved for this indication used in this study Cutting balloon has already been approved as a treatment option for treating coronary calcified lesions All human and animal studies were approved by the appropriate ethics committee and were therefore performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments In addition this study will be approved by the ethics committee of each participating hospital and center
2 Study Objective Calcified coronary lesions respond inappropriately to conventional balloon angioplasty resulting in inadequate lesion preparation and incomplete stent expansion This prospective randomized study aims to evaluate the safety and efficacy of cutting balloon angioplasty for various degrees of calcified coronary lesions treated with a novel bioabsorbable polymer-coated everolimus-eluting coronary stent
1 Which clinical question shall be answered Heavily calcified lesions respond poorly to conventional balloon angioplasty when stents are implanted in incompletely modified lesions resulting in incomplete and asymmetrical stent expansion Inadequate calcium and plaque modification is related to worse clinical outcomes In addition incomplete modification and preparation of calcified lesions adversely affect the number of balloons amount of contrast procedure time and stent delivery failure Periprocedural factors such as the amount of contrast medium and procedure time are also known to be related to adverse clinical outcomes and in-hospital complication rates Various devices such as cutting balloons spiral balloons and rotational atherectomy devices have been used to modify calcium lesions The cutting balloon has four blades surrounding the balloon When the balloon is inflated the blades initiate a score into the plaque after which the shear force applied by the balloon inflation propagates the crack and results in lumen enlargement However evidence related to use of the cutting balloon for various degrees of calcified lesions is limited In addition despite the advantages of the cutting balloon in the treatment of calcium lesions investigations designed to focus on intraprocedural and operator-oriented endpoints such as the number of balloons used procedure time and the total amount of contrast medium used are also rare Moreover bioabsorbable polymer-coated coronary stents have proven to be safe and effective for the treatment of coronary artery diseases including calcified lesions Therefore in this study the investigators aim to evaluate the safety and efficacy including intraprocedural and operator-oriented outcomes of a novel cutting balloon Wolverine Boston Scientific Natick MassachusettsMA USA compared with a non-compliant NC balloon in the treatment of patients with various degrees of calcified lesions including mild to heavily calcified lesions who are treated with intravascular ultrasound IVUS guided bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy Boston Scientific Corporation Marlborough MA USA implantation
2 To what degree has this question already been investigated elsewhere What are the differentiators to already published studies The Wolverine balloon Boston Scientific Corporation is a novel cutting balloon mounted on a semi-compliant balloon with three or four arthrotomies bonded longitudinally to its surface Some studies on the use of cutting balloons in the treatment of coronary arteries have been previously reported but most of them investigated moderately or severely calcified lesions compared with NC balloons Another limitation of previous studies is that they included a small number of patients and had a retrospective design In addition previous studies have mainly focused on periprocedural outcomes based on imaging studies such as acute luminal gain and cross-sectional areaCSA using IVUS
In this study the indication of a cutting balloon is not limited to severe calcified coronary artery disease but expanded to mild calcified coronary artery disease including in-stent restenosisISR to achieve optimal preconditioning for stent implantation through active calcium modification Apart from the acute phase per-procedural gain of calcium modification the investigators aim to investigate the long-term endpoints such as major adverse cardiac eventsMACE with aggressive calcium modification and an appropriate type of drug-eluting stent implantation This trial is to be conducted using a bioabsorbable polymer-coated drug-eluting coronary stent The SYNERGY stent Boston Scientific Corporation Marlborough MA USA is a thin strut 74 μm of platinum-chromium metal alloy that elutes everolimus from an ultrathin 4 μm bioabsorbable polymer applied only to the abluminal surface of the stent and resolves within 4 months After the absorption period of the polymer only ultrathin 70 or 80 μm stent struts remain and ultrathin stent struts improve clinical outcomes in the treatment of various coronary artery diseases
Previously a few studies have reported the stent crossability of novel cutting balloons for treating calcium lesions However studies focusing on intraprocedural operator-centric factors such as the procedure time amount of contrast medium and number of balloons used are lacking As previously reported periprocedural and intraprocedural factors such as the amount of contrast medium and procedure time are also related to adverse clinical outcomes in the complex percutaneous coronary interventionPCI era As Effect of cutting balloon after rotational atherectomy in severely calcified coronary artery lesions as assessed by optical coherence tomography reported the low crossability of the old model cutting balloon makes the operator hesitant to choose a cutting balloon as a first-line option in the treatment of the calcified lesion However the crossability of the novel cutting balloon Wolverine was improved and proved to have a higher delivery success rate caused by the induction of superior crossability derived from active calcium modification In addition owing to the development of balloon platform technologies there have been reports on the improvement of stent and balloon crossability in the treatment of calcium lesions with novel cutting balloons compared with old cutting or scoring balloons In our study the investigators additionally focus on intraprocedural and operator-centric outcomes and the total procedure time number of balloons and amount of contrast medium used are set as the parameters of the secondary endpoints
In conclusion this study evaluates the efficacy and safety of the novel cutting balloon Wolverine compared to the NC balloon in treating patients with calcified coronary lesions undergoing PCI It aims to provide insights into the optimal type of balloons for modifying calcium lesions Additionally the study seeks to broaden the application of the cutting balloon exploring its use in a range of coronary calcified lesions from mild to severe This comparative approach extends to assessing clinical benefits including intraprocedural and periprocedural outcomes as well as factors like the total number of balloons used procedure time and contrast amount for enhanced operator convenience Furthermore the study intends to demonstrate the mid- to long-term clinical advantages of using cutting balloons for aggressive modification of calcified lesions followed by the implantation of bioabsorbable polymer-coated everolimus-eluting coronary stents Synergy Boston Scientific Corporation Marlborough MA USA Lastly given the limited insurance coverage for cutting balloons in some countries this research also aims to substantiate their use in treating mild stenosis and ISR lesions potentially influencing broader insurance policy inclusion
3 Can this question only be answered by a clinical investigation Although the use of a cutting balloon in the treatment of heavy calcified lesions has been previously proven the investigators believe that clinical studies are needed to demonstrate the effectiveness of treatment of various calcium lesions including restenosis through this study In addition since it is a study that requires results through imaging tests and long-term clinical observation it is necessary to conduct clinical research As the basis for the safety of cutting balloons has been sufficiently proven in previous clinical studies it is considered that there are no ethical problems
4 Why and for whom is it important to perform this study The investigators evaluate the efficacy and safety of the novel cutting balloon Wolverine in patients with calcified coronary lesions undergoing PCI and will provide rationale for which type of balloons will optimally modify the calcium lesions In addition the investigators attempt to expand the indications of the cutting balloon for the treatment of mild to severe coronary calcified lesions by conducting a comparative study of the NC and cutting balloons in the treatment of calcified lesions
The investigators aim to investigate the clinical benefits of intraprocedural and periprocedural outcomes and operator convenience such as the number of total balloons used procedure time and amount of contrast The scope of insurance coverage for cutting balloons remains limited in some countries therefore this study aims to provide evidence for extending insurance coverage to the treatment of mild stenosis and ISR lesions
5 What and how will Boston Scientific technology be used The following devices will be used 1 Wolverine Boston Scientific Natick MA USA cutting balloon 2 bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy Boston Scientific Corporation Marlborough MA USA and 3 NC balloon the type of NC balloon will be decided at the operators discretion
PCI and stent implantation will be performed according to the current guidelines using standard interventional techniques The interventional strategy balloon size and stent selection will be based on the discretion of the same operator for all patients Modification of the atheroma using rota-ablation will be performed at the operators discretion in cases of balloon-uncrossable lesions and these cases will be excluded from enrollment After pre-dilation all patients would be treated with bioabsorbable polymer-coated everolimus-eluting coronary stent Synergy Boston Scientific Corporation Marlborough MA USA After regular coronary angiography IVUS will be performed at baseline before pre-dilatation and repeated immediately after stent implantation in all cases IVUS will be performed using an OptiCross 60 MHz Scientific Corporation Maple Grove MinnesotaMN USA After intracoronary injection of nitroglycerin the IVUS catheter will be carefully advanced distal to the culprit lesion under fluoroscopic guidance and then withdrawn automatically at 05 mms to perform the imaging sequence which begins 20 mm distal to the culprit lesion and ends at the aorto-ostial junction
6 Is the device approved for this indication used in this study Cutting balloon has already been approved as a treatment option for treating coronary calcified lesions All human and animal studies were approved by the appropriate ethics committee and were therefore performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments In addition this study will be approved by the ethics committee of each participating hospital and center
2 Study Objective Calcified coronary lesions respond inappropriately to conventional balloon angioplasty resulting in inadequate lesion preparation and incomplete stent expansion This prospective randomized study aims to evaluate the safety and efficacy of cutting balloon angioplasty for various degrees of calcified coronary lesions treated with a novel bioabsorbable polymer-coated everolimus-eluting coronary stent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None