Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial.
Salvatore Cassese, Fiorenzo Simonetti, Hector Alfonso Alvarez Covarrubias...
https://pubmed.ncbi.nlm.nih.gov/39710352Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07093788
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2026-03-10
78
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different preparation techniques for severely calcified coronary lesions in patients undergoing percutaneous coronary intervention (PCI). The trial compares the effects of a super high-pressure balloon and intravascular lithotripsy (IVL) on stent expansion and safety. Calcified plaques make stent placement challenging and increase the risk of treatment failure, so finding optimal preparation methods is important. Participants receive PCI guided by intravascular imaging using either the super high-pressure balloon or IVL to prepare the calcified lesions before stent implantation. The super high-pressure balloon is a novel device that can expand uniformly under extreme pressure. IVL uses sonic pressure pulses to fracture calcium plaques within the artery. Both methods are being studied to determine their effectiveness and safety in this setting. During the study, stent expansion is measured using intraprocedural imaging techniques such as optical coherence tomography or intravascular ultrasound. Researchers also monitor major adverse cardiac events within 30 days after the procedure. Participants will be assessed throughout the PCI procedure and followed up to evaluate outcomes. The total participation duration includes the procedure and at least a 30-day safety follow-up.
CONDITIONS
Brief Title
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years and under 80 years
- Presented with asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI)
- Indication for drug-eluting stent (DES) implantation
- Denovo coronary artery calcified lesions
- Target lesion diameter stenosis at least 70%, or between 50% and less than 70% with 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 and 4.5 mm
- Maximum calcium arc within the lesion at least 270° assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
- Unsatisfactory lesion preparation with non-compliant balloon, defined as less than 30% diameter stenosis reduction under maximal inflation pressure
- Provision of written informed consent
You will not qualify if you...
- Presented with acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock, or multiple organ failure
- Severe allergy to contrast agents
- Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo intravascular imaging-guided PCI and receive lesion preparation using either super high-pressure balloon or intravascular lithotripsy (IVL) as part of the treatment.
1 treatment visit (in-person)
Follow-up
Duration - 30 days
Participants are monitored for safety and efficacy outcomes including assessment of major adverse cardiac events (MACE) within 30 days after the procedure.
1 follow-up visit within 30 days (in-person)
Trial Site Locations
Total: 3 locations
1
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China, 222000
Actively Recruiting
2
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
3
Yixing People's Hospital
Yixing, Jiangsu, China, 214200
Actively Recruiting
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Research Team
F
Fei Ye, MD
Y
Yi-fei Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.
Marios Sagris, Nikolaos Ktenopoulos, Kyriakos Dimitriadis...
https://pubmed.ncbi.nlm.nih.gov/38482928Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial.
Tobias Rheude, Himanshu Rai, Gert Richardt...
https://pubmed.ncbi.nlm.nih.gov/33258774Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.
Tobias Rheude, Sean Fitzgerald, Abdelhakim Allali...
https://pubmed.ncbi.nlm.nih.gov/36137691