Shockwave IVL + DCB
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Calcified Lesions in Small Coronary Vessels. Basic parameters: from 18 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
- Brazil, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study
Overview
Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and/or distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions. This study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.
Primary outcome measures
- Successful IVL plus DCB [Time frame: at 1 month follow-up]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:
- De novo lesion with diameter stenosis > 50% (visual analysis)
- Coronary vessel diameter < 3.0 mm (visual analysis)
- Severe calcification at the target segment, defined as fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location OR Intravascular Ultrasound/Optical Coherence Tomography (IVUS/OCT) demonstrated calcium angle of ≥270° on at least 1 cross section.
- Written informed consent
Exclusion criteria
- Previous coronary intervention at or < 10 mm distant from target segment at any time.
- Lesion length ≥ 40 mm.
- Planned atherectomy or cutting/scoring balloon use.
- Bifurcation lesion.
- Thrombus containing lesion.
- Life expectancy < 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Brazil · 1 center
- Hospital Israelita Albert Einstein — São Paulo
Italy · 1 center
- University of Verona — Verona
Identifiers
NCT: NCT05625997 · RO-220203