Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions

NCT07093788 | Recruiting

• 1 other identifier: KY20250425-03
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Conditions

PCI; Coronary Arterial Disease (CAD); Calcified Coronary Lesions

Keywords

super high-pressure balloon; percutaneous coronary intervention; intravascular lithotripsy

Outcome Measures

Primary Outcomes (1)

• stent expansion index

  The stent expansion was associated with post-PCI clinical outcomes and the risk of stent failure.In this study, the primary endpoint was stent expansion index, which was defined as the final minimal luminal area (MLA) within the treated segment divided by the average reference vessel area assessed with intravascular imaging (optical coherence tomography(OCT)\&intravascular ultrasound(IVUS)).

  Intraprocedural

Secondary Outcomes (1)

• 30-days major adverse cardiac event (MACE)

  30 days

Study Arms (2)

Super high-pressure balloon

EXPERIMENTAL

Patients underwent intravascular imaging -guided PCI were treated with super high-pressure balloon for lesion preparation.

Device: super high-pressure balloon

Intravascular lithotripsy (IVL)

EXPERIMENTAL

Patients underwent intravascular imaging -guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation.

Device: intravascular lithotripsy (IVL)

Interventions

super high-pressure balloon DEVICE

preparation strategy for calcified lesions after unsatisfactory dilation

Super high-pressure balloon

intravascular lithotripsy (IVL) DEVICE

preparation strategy for calcified lesions after unsatisfactory dilation

Intravascular lithotripsy (IVL)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 80 years
• Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
• Have an indication for drug-eluting stent (DES) implantation
• Denovo coronary artery calcified lesions
• Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \< 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
• Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
• Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
• Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \< 30% under maximal inflation pressure.
• Provision of written informed consent

You may not qualify if:

• Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
• Presented as severe contrast agent allergy
• Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
• Presented as active phase of autoimmune disease
• Calcified nodules or eccentric calcification lesions
• Failure to reach the target lesion with guidewires or catheters
• Complex coronary bifurcation lesions
• Target vessel thrombosis or aneurysm within 10 mm of the target lesion

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (3)

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222000, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Yixing People's Hospital

Yixing, Jiangsu, 214200, China

RECRUITING

Related Publications (4)

• Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20.

  PMID: 39710352 BACKGROUND

• Sagris M, Ktenopoulos N, Dimitriadis K, Papanikolaou A, Tzoumas A, Terentes-Printzios D, Synetos A, Soulaidopoulos S, Lichtenberg M, Korosoglou G, Honton B, Tousoulis D, Tsioufis C, Toutouzas K. Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Apr;103(5):710-721. doi: 10.1002/ccd.31006. Epub 2024 Mar 14.

  PMID: 38482928 BACKGROUND

• Rheude T, Rai H, Richardt G, Allali A, Abdel-Wahab M, Sulimov DS, Mashayekhi K, Ayoub M, Cuculi F, Bossard M, Kufner S, Xhepa E, Kastrati A, Fusaro M, Joner M, Byrne RA, Cassese S. Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial. EuroIntervention. 2021 Aug 27;17(6):481-488. doi: 10.4244/EIJ-D-20-01000.

  PMID: 33258774 BACKGROUND

• Rheude T, Fitzgerald S, Allali A, Mashayekhi K, Gori T, Cuculi F, Kufner S, Hemetsberger R, Sulimov DS, Rai H, Ayoub M, Bossard M, Xhepa E, Fusaro M, Toelg R, Joner M, Byrne RA, Richardt G, Kastrati A, Cassese S, Abdel-Wahab M. Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions. JACC Cardiovasc Interv. 2022 Sep 26;15(18):1864-1874. doi: 10.1016/j.jcin.2022.07.034.

  PMID: 36137691 BACKGROUND

Study Officials

• Fei Ye, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ye, MD

CONTACT

18951670287; doctor_ye@126.com

Yi-fei Wang, MD

CONTACT

18852577798; happywangyf2018@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)