Coronary Artery DiseaseNCT06177808

Assessment of Cutting-Balloon Angioplasty With Everolimus-Eluting Stent(EES) in the Treatment of Coronary Calcified Lesion(CCL) Guided by Intravascular Ultrasonography(IVUS)

A study testing Wolverine cutting balloon and Non-compliant balloon in people with Coronary Artery Disease, run by Soonchunhyang University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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™). Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Wolverine cutting balloon and Non-compliant balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteSouth Korea
Study dates: 1 Jan 2024to 31 Dec 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 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Coronary artery disease including ISR or de novo lesion with a stenosis of ≥ 70%
Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies
A reference vessel diameter between 2.0 and 4.0mm and deemed suitable for PCI

Who cannot join

Extremely tortuous or angulated lesions
Lesions with dissection before balloon pre-dilatation
Lesions within the vein graft
Extremely narrow lesions which need to rotational atherectomy
STEMI
Comorbidities which preclude the achievement of one year follow up

Trial locations and contacts

1 site in 1 country.

Jon Suh, PhD contact

Eunbin Park contact

South Korea1 site, 1 recruiting

Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, 14584
Jon Suh, PhD, 082-10-3407-3843, immanuel@schmc.ac.kr
Eunbin Park, 082-10-9180-7781, popori114@naver.com
Recruiting

Other trials in South Korea

About this study

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

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.

Read the detailed description

Background
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, Massachusetts(MA), 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.
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 area(CSA) 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 restenosis(ISR), 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 events(MACE) 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 intervention(PCI) 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.
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.
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.
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 operator's 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 operator's 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, Minnesota(MN), 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 0.5 mm/s to perform the imaging sequence, which begins 20 mm distal to the culprit lesion and ends at the aorto-ostial junction.
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.
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.

Conditions: Coronary Artery Disease
Being tested: Wolverine cutting balloon, Non-compliant balloon
Keywords: Cutting balloon, Calcified coronary lesion, Calcium modification, Balloon angioplasty, Intravascular ultrasound
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.

Wolverine cutting balloonDevice
As an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Wolverine cutting balloon for calcium modification.
Non-compliant balloonDevice
As an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Non-compliant balloon for calcium modification.

Study groups in NCT06177808
Study group	Role	What they receive
Wolverine cutting balloon group	Experimental	Patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion Receives: Device: Wolverine cutting balloon
NC(Non-compliant) balloon group	Active comparator	Patients who received PCI with Non-compliant balloon to modify calcified coronary lesion Receives: Device: Non-compliant balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

Minimal stent CSA (cross-section area) with IVUS at calcium site
Minimal stent CSA (cross-section area) with IVUS at calcium site after modification using Wolverine cutting balloon or non-compliant(NC) balloon
Measured: From date of randomization until the date of CSA(cross-section area) analysis, assessed up to one year.

Secondary outcomes (9)

All-cause death
All-cause death during 1year follow-up after index procedure
Measured: From after the index procedure up to one year.
Cardiovascular death
Cardiovascular death during 1year follow-up after index procedure
Measured: From after the index procedure up to one year.
Myocardial infarction(MI)
MI during 1year follow-up after index procedure
Measured: From after the index procedure up to one year.
Target vascular revascularization(TVR)
TVR during 1year follow-up after index procedure
Measured: From after the index procedure up to one year.
Target lesion revascularization(TLR)
TLR during 1year follow-up after index procedure
Measured: From after the index procedure up to one year.
Procedure time
Total procedure time of the index procedure
Measured: From after the index procedure up to one year.
Total amount of contrast
Total amount of contrast used in the index procedure
Measured: From after the index procedure up to one year.
The number of balloons
The total number of balloons used in the index procedure
Measured: From after the index procedure up to one year.
Major adverse cardiac event(MACE)
MACE during 1year follow-up after index procedure
: The number of cardiovascular death, TVR, MI will be combined to report the number of MACE
Measured: From after the index procedure up to one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Dec 2025

First posted20 Dec 2023
Study start1 Jan 2024 (estimated)
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
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
Model description: Intervention group : patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion; Control group : patients who received PCI with Non-compliant balloon to modify calcified coronary lesion
Masking: None (open label)
Enrolment: 250 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06177808
Sponsor's protocol ID: JSuh
Status last verified: Dec 2023
First submitted: 12 Nov 2023
Last updated: 3 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Vavuranakis M, Toutouzas K, Stefanadis C, Chrisohou C, Markou D, Toutouzas P. Stent deployment in calcified lesions: can we overcome calcific restraint with high-pressure balloon inflations? Catheter Cardiovasc Interv. 2001 Feb;52(2):164-72. doi: 10.1002/1522-726x(200102)52:23.0.co;2-s.
PubMed 11170322
Vliegenthart R, Oudkerk M, Hofman A, Oei HH, van Dijck W, van Rooij FJ, Witteman JC. Coronary calcification improves cardiovascular risk prediction in the elderly. Circulation. 2005 Jul 26;112(4):572-7. doi: 10.1161/CIRCULATIONAHA.104.488916. Epub 2005 Jul 11.
PubMed 16009800
Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64.
PubMed 1617791
Tan K, Sulke N, Taub N, Sowton E. Clinical and lesion morphologic determinants of coronary angioplasty success and complications: current experience. J Am Coll Cardiol. 1995 Mar 15;25(4):855-65. doi: 10.1016/0735-1097(94)00462-Y.
PubMed 7884088
Zaidan M, Alkhalil M, Alaswad K. Calcium Modification Therapies in Contemporary Percutaneous Coronary Intervention. Curr Cardiol Rev. 2022;18(1):e281221199533. doi: 10.2174/1573403X18666211228095457.
PubMed 34963434
Aksoy A, Salazar C, Becher MU, Tiyerili V, Weber M, Jansen F, Sedaghat A, Zimmer S, Leick J, Grube E, Gonzalo N, Sinning JM, Escaned J, Nickenig G, Werner N. Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry. Circ Cardiovasc Interv. 2019 Nov;12(11):e008154. doi: 10.1161/CIRCINTERVENTIONS.119.008154. Epub 2019 Nov 11.
PubMed 31707803
Tajti P, Ayoub M, Nuehrenberg T, Ferenc M, Behnes M, Buettner HJ, Neumann FJ, Mashayekhi K. Association of Prolonged Fluoroscopy Time with Procedural Success of Percutaneous Coronary Intervention for Stable Coronary Artery Disease with and without Chronic Total Occlusion. J Clin Med. 2021 Apr 3;10(7):1486. doi: 10.3390/jcm10071486.
PubMed 33916666
Feng YQ, He XY, Song FE, Chen JY. Association between Contrast Media Volume and 1-Year Clinical Outcomes in Patients Undergoing Coronary Angiography. Chin Med J (Engl). 2018 Oct 20;131(20):2424-2432. doi: 10.4103/0366-6999.243563.
PubMed 30334527
Jinnouchi H, Kuramitsu S, Shinozaki T, Hiromasa T, Kobayashi Y, Takeji Y, Miura M, Masuda H, Matsumura Y, Yamaji Y, Sakakura K, Domei T, Soga Y, Hyodo M, Shirai S, Ando K. Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions. Circ J. 2018 Mar 23;82(4):983-991. doi: 10.1253/circj.CJ-17-0564. Epub 2017 Sep 9.
PubMed 28890526
Li Q, He Y, Chen L, Chen M. Intensive plaque modification with rotational atherectomy and cutting balloon before drug-eluting stent implantation for patients with severely calcified coronary lesions: a pilot clinical study. BMC Cardiovasc Disord. 2016 May 26;16:112. doi: 10.1186/s12872-016-0273-8.
PubMed 27230875
Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, Di Mario C, Colombo A. Cutting balloon angioplasty for treatment of calcified coronary lesions. Catheter Cardiovasc Interv. 2001 Dec;54(4):473-81. doi: 10.1002/ccd.1314.
PubMed 11747183
Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv. 2020 Sep;13(9):e009189. doi: 10.1161/CIRCINTERVENTIONS.120.009189. Epub 2020 Sep 8.
PubMed 32895004
Barbato E, Shlofmitz E, Milkas A, Shlofmitz R, Azzalini L, Colombo A. State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey. EuroIntervention. 2017 Aug 25;13(6):696-705. doi: 10.4244/EIJ-D-17-00473.
PubMed 28844031
Kinoshita Y, Iwasaki K, Suzuki T. Verification of the differences of scoring effect in current scoring balloons. Cardiovasc Interv Ther. 2022 Jul;37(3):513-518. doi: 10.1007/s12928-021-00807-1. Epub 2021 Aug 25.
PubMed 34432207
Zhang M, Matsumura M, Usui E, Noguchi M, Fujimura T, Fall KN, Zhang Z, Nazif TM, Parikh SA, Rabbani LE, Kirtane AJ, Collins MB, Leon MB, Moses JW, Karmpaliotis D, Ali ZA, Mintz GS, Maehara A. Intravascular Ultrasound-Derived Calcium Score to Predict Stent Expansion in Severely Calcified Lesions. Circ Cardiovasc Interv. 2021 Oct;14(10):e010296. doi: 10.1161/CIRCINTERVENTIONS.120.010296. Epub 2021 Oct 19.
PubMed 34665658

Want to know more?

Jon Suh, PhD

082-10-3407-3843

immanuel@schmc.ac.kr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06177808
Acronym / sponsor ID: JSuh
Conditions: Coronary Artery Disease
Keywords: Cutting balloon, Calcified coronary lesion, Calcium modification, Balloon angioplasty, Intravascular ultrasound
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 250 participants (estimated)
Lead sponsor: Soonchunhyang University HospitalUniversity, hospital or other
Collaborators: Boston Scientific Corporation, Eulji University, The Catholic University of Korea, Hanil General Hospital, Korea
Study start: 1 Jan 2024 (estimated)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 20 Dec 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.

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

Background
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, Massachusetts(MA), 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.
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 area(CSA) 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 restenosis(ISR), 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 events(MACE) 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 intervention(PCI) 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.
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.
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.
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 operator's 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 operator's 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, Minnesota(MN), 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 0.5 mm/s to perform the imaging sequence, which begins 20 mm distal to the culprit lesion and ends at the aorto-ostial junction.
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.
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Intervention group : patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion; Control group : patients who received PCI with Non-compliant balloon to modify calcified coronary lesion

Arm	Type	Receives
Wolverine cutting balloon group	Experimental	Device: Wolverine cutting balloonPatients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion
NC(Non-compliant) balloon group	Active comparator	Device: Non-compliant balloonPatients who received PCI with Non-compliant balloon to modify calcified coronary lesion

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Coronary artery disease including ISR or de novo lesion with a stenosis of ≥ 70%
Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies
A reference vessel diameter between 2.0 and 4.0mm and deemed suitable for PCI

Key exclusion criteria (6 listed)

Extremely tortuous or angulated lesions
Lesions with dissection before balloon pre-dilatation
Lesions within the vein graft
Extremely narrow lesions which need to rotational atherectomy
STEMI

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
Wolverine cutting balloonAs an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Wolverine cutting balloon for calcium modification.	Device	Wolverine cutting balloon group
Non-compliant balloonAs an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Non-compliant balloon for calcium modification.	Device	NC(Non-compliant) balloon group

Primary outcome

Minimal stent CSA (cross-section area) with IVUS at calcium site
Time frame: From date of randomization until the date of CSA(cross-section area) analysis, assessed up to one year.
Minimal stent CSA (cross-section area) with IVUS at calcium site after modification using Wolverine cutting balloon or non-compliant(NC) balloon

9 secondary outcomes

All-cause death
Time frame: From after the index procedure up to one year.
Cardiovascular death
Time frame: From after the index procedure up to one year.
Myocardial infarction(MI)
Time frame: From after the index procedure up to one year.
Target vascular revascularization(TVR)
Time frame: From after the index procedure up to one year.
Target lesion revascularization(TLR)
Time frame: From after the index procedure up to one year.
Procedure time
Time frame: From after the index procedure up to one year.
Total amount of contrast
Time frame: From after the index procedure up to one year.
The number of balloons
Time frame: From after the index procedure up to one year.
Major adverse cardiac event(MACE)
Time frame: From after the index procedure up to one year.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Background: PubMed 11170322Vavuranakis M, Toutouzas K, Stefanadis C, Chrisohou C, Markou D, Toutouzas P. Stent deployment in calcified lesions: can we overcome calcific restraint with high-pressure balloon inflations? Catheter Cardiovasc Interv. 2001 Feb;52(2):164-72. doi: 10.1002/1522-726x(200102)52:23.0.co;2-s.
Background: PubMed 16009800Vliegenthart R, Oudkerk M, Hofman A, Oei HH, van Dijck W, van Rooij FJ, Witteman JC. Coronary calcification improves cardiovascular risk prediction in the elderly. Circulation. 2005 Jul 26;112(4):572-7. doi: 10.1161/CIRCULATIONAHA.104.488916. Epub 2005 Jul 11.
Background: PubMed 1617791Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64.
Background: PubMed 7884088Tan K, Sulke N, Taub N, Sowton E. Clinical and lesion morphologic determinants of coronary angioplasty success and complications: current experience. J Am Coll Cardiol. 1995 Mar 15;25(4):855-65. doi: 10.1016/0735-1097(94)00462-Y.
Background: PubMed 34963434Zaidan M, Alkhalil M, Alaswad K. Calcium Modification Therapies in Contemporary Percutaneous Coronary Intervention. Curr Cardiol Rev. 2022;18(1):e281221199533. doi: 10.2174/1573403X18666211228095457.
Background: PubMed 31707803Aksoy A, Salazar C, Becher MU, Tiyerili V, Weber M, Jansen F, Sedaghat A, Zimmer S, Leick J, Grube E, Gonzalo N, Sinning JM, Escaned J, Nickenig G, Werner N. Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry. Circ Cardiovasc Interv. 2019 Nov;12(11):e008154. doi: 10.1161/CIRCINTERVENTIONS.119.008154. Epub 2019 Nov 11.
Background: PubMed 33916666Tajti P, Ayoub M, Nuehrenberg T, Ferenc M, Behnes M, Buettner HJ, Neumann FJ, Mashayekhi K. Association of Prolonged Fluoroscopy Time with Procedural Success of Percutaneous Coronary Intervention for Stable Coronary Artery Disease with and without Chronic Total Occlusion. J Clin Med. 2021 Apr 3;10(7):1486. doi: 10.3390/jcm10071486.
Background: PubMed 30334527Feng YQ, He XY, Song FE, Chen JY. Association between Contrast Media Volume and 1-Year Clinical Outcomes in Patients Undergoing Coronary Angiography. Chin Med J (Engl). 2018 Oct 20;131(20):2424-2432. doi: 10.4103/0366-6999.243563.
Background: PubMed 28890526Jinnouchi H, Kuramitsu S, Shinozaki T, Hiromasa T, Kobayashi Y, Takeji Y, Miura M, Masuda H, Matsumura Y, Yamaji Y, Sakakura K, Domei T, Soga Y, Hyodo M, Shirai S, Ando K. Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions. Circ J. 2018 Mar 23;82(4):983-991. doi: 10.1253/circj.CJ-17-0564. Epub 2017 Sep 9.
Background: PubMed 27230875Li Q, He Y, Chen L, Chen M. Intensive plaque modification with rotational atherectomy and cutting balloon before drug-eluting stent implantation for patients with severely calcified coronary lesions: a pilot clinical study. BMC Cardiovasc Disord. 2016 May 26;16:112. doi: 10.1186/s12872-016-0273-8.
Background: PubMed 11747183Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, Di Mario C, Colombo A. Cutting balloon angioplasty for treatment of calcified coronary lesions. Catheter Cardiovasc Interv. 2001 Dec;54(4):473-81. doi: 10.1002/ccd.1314.
Background: PubMed 32895004Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv. 2020 Sep;13(9):e009189. doi: 10.1161/CIRCINTERVENTIONS.120.009189. Epub 2020 Sep 8.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Jon Suh, PhD contact

Eunbin Park contact

Jon Suh, PhD study chair

Soonchunhyang University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wolverine cutting balloon and Non-compliant balloon in people with Coronary Artery Disease, run by Soonchunhyang University Hospital at 1 site in South Korea.

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 6 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jon Suh, PhD (082-10-3407-3843, immanuel@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal stent CSA (cross-section area) with IVUS at calcium site (time frame: From date of randomization until the date of CSA(cross-section area) analysis, assessed up to one year.). 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 NCT06177808, which also lists 19 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 3 Jan 2024.