Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 78
- Locations
- 6
- Primary Endpoint
- stent expansion index
Study Overview
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Super high-pressure balloon
Patients underwent intravascular imaging -guided PCI were treated with super high-pressure balloon for lesion preparation.
Intervention: super high-pressure balloon (Device)
Intravascular lithotripsy (IVL)
Patients underwent intravascular imaging -guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation.
Intervention: intravascular lithotripsy (IVL) (Device)
Outcomes
Primary Outcomes
stent expansion index
Time Frame: Intraprocedural
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)).
Secondary Outcomes
- 30-days major adverse cardiac event (MACE)(30 days)
Investigators
Ye-fei
chief physician
Nanjing First Hospital, Nanjing Medical University