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

NCT06177808 | Unknown DMC FDA Device

• 1 other identifier: JSuh
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Cutting balloon; Calcified coronary lesion; Calcium modification; Balloon angioplasty; Intravascular ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  From date of randomization until the date of CSA(cross-section area) analysis, assessed up to one year.

Secondary Outcomes (9)

• All-cause death

  From after the index procedure up to one year.

• Cardiovascular death

  From after the index procedure up to one year.

• Myocardial infarction(MI)

  From after the index procedure up to one year.

• Target vascular revascularization(TVR)

  From after the index procedure up to one year.

• Target lesion revascularization(TLR)

  From after the index procedure up to one year.

Study Arms (2)

Wolverine cutting balloon group

EXPERIMENTAL

Patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion

Device: Wolverine cutting balloon

NC(Non-compliant) balloon group

ACTIVE COMPARATOR

Patients who received PCI with Non-compliant balloon to modify calcified coronary lesion

Device: Non-compliant balloon

Interventions

Wolverine cutting balloon DEVICE

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

Wolverine cutting balloon group

Non-compliant balloon DEVICE

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

NC(Non-compliant) balloon group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead
• Boston Scientific Corporation: collaborator
• Eulji University: collaborator
• The Catholic University of Korea: collaborator
• Hanil General Hospital, Korea: collaborator

Study Sites (1)

Soonchunhyang University Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

RECRUITING

Related Publications (19)

• 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.

  PMID: 11170322 BACKGROUND

• 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.

  PMID: 16009800 BACKGROUND

• 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.

  PMID: 1617791 BACKGROUND

• 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.

  PMID: 7884088 BACKGROUND

• 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.

  PMID: 34963434 BACKGROUND

• 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.

  PMID: 31707803 BACKGROUND

• 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.

  PMID: 33916666 BACKGROUND

• 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.

  PMID: 30334527 BACKGROUND

• 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.

  PMID: 28890526 BACKGROUND

• 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.

  PMID: 27230875 BACKGROUND

• 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.

  PMID: 11747183 BACKGROUND

• 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.

  PMID: 32895004 BACKGROUND

• 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.

  PMID: 28844031 BACKGROUND

• 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.

  PMID: 34432207 BACKGROUND

• 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.

  PMID: 34665658 BACKGROUND

• Matsukawa R, Kozai T, Tokutome M, Nakashima R, Nishimura R, Matsumoto S, Katsuki M, Masuda S, Meno H. Plaque modification using a cutting balloon is more effective for stenting of heavily calcified lesion than other scoring balloons. Cardiovasc Interv Ther. 2019 Oct;34(4):325-334. doi: 10.1007/s12928-019-00578-w. Epub 2019 Feb 15.

  PMID: 30771163 BACKGROUND

• Ishihara T, Iida O, Takahara M, Tsujimura T, Okuno S, Kurata N, Asai M, Okamoto S, Nanto K, Mano T. Improved crossability with novel cutting balloon versus scoring balloon in the treatment of calcified lesion. Cardiovasc Interv Ther. 2021 Apr;36(2):198-207. doi: 10.1007/s12928-020-00663-5. Epub 2020 Mar 28.

  PMID: 32222901 BACKGROUND

• Tang Z, Bai J, Su SP, Wang Y, Liu MH, Bai QC, Tian JW, Xue Q, Gao L, An CX, Liu XJ. Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions. J Geriatr Cardiol. 2014 Mar;11(1):44-9. doi: 10.3969/j.issn.1671-5411.2014.01.012.

  PMID: 24748881 BACKGROUND

• Ahn J, Yu H, Park S, Suh J. Assessment of Cutting-Balloon Angioplasty with Novel Bioabsorbable Polymer-Coated Everolimus-Eluting Stent in Treating Calcified Coronary Lesions Guided by Intravascular Ultrasound (CUPID Trial): study design and protocol. Trials. 2024 Oct 29;25(1):727. doi: 10.1186/s13063-024-08484-0.

  PMID: 39472953 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jon Suh, PhD

  Soonchunhyang University Hospital

  STUDY CHAIR

Central Study Contacts

Jon Suh, PhD

CONTACT

082-10-3407-3843; immanuel@schmc.ac.kr

Eunbin Park

CONTACT

082-10-9180-7781; popori114@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jon Suh, MD/PhD, Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 20, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)