Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: super high-pressure balloon, intravascular lithotripsy (IVL).
- Who it may be relevant to
- Registry conditions: PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
Overview
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
Detailed description
Calcified lesions posed a significant challenge in percutaneous coronary intervention (PCI). The existence of calcified plaque increased the difficulty of optimal stent expansion and the risk of target lesion failure(TLF). Consequently, optimizing the preparation techniques for calcified lesions before stent implantation has assumed growing importance.
As a kind of novel double-layered balloon, super high-pressure balloon can expand uniformly under extreme pressure. Previous studies have demonstrated that super high-pressure balloon perform non-inferiorly or superiorly to other strategies in terms of final stent expansion.
Through triggering localized pulsatile sonic pressure, intravascular lithotripsy(IVL) cracked intimal and medial calcium plaque within the artery. In present series of studies(DISRUPT), the optimized preparation of calcified lesions with IVL has been proved to be safe and effective. According to guidelines and clinical practice, IVL is applicable to different types of severe calcification lesions, including concentric and eccentric calcifications. However, considering its technological and economic costs, finding other preparation techniques non-inferiority to IVL was essential. In clinical practice, super high-pressure balloon had shown considerable effects of preparation for calcified lesions. However, study focused on the comparison of super high-pressure balloon with IVL for severe calcified lesions was limited.
In summary, this randomized trial aimed to evaluate the stent expansion through intravascular imaging among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
Interventions
- Device super high-pressure balloon
preparation strategy for calcified lesions after unsatisfactory dilation - Device intravascular lithotripsy (IVL)
preparation strategy for calcified lesions after unsatisfactory dilation
Primary outcome measures
- stent expansion index [Time frame: Intraprocedural]
Secondary outcome measures (1)
- 30-days major adverse cardiac event (MACE) [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Lianyungang First People's Hospital — Lianyungang
- Nanjing First Hospital — Nanjing
- Yixing People's Hospital — Yixing
Publications
- 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
- 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: 10.1 PMID 38482928
- 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
- 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 PMID 36137691
Identifiers
NCT: NCT07093788 · KY20250425-03