Shockwave IVL + DCB

Study Overview
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Brief Summary
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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.

Official Title
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Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study

Conditions
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Calcified Lesions in Small Coronary Vessels

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful IVL plus DCB | Successful IVL plus DCB in the absence of target lesion failure (TLF); Successful IVL plus DCB will be defined as a composite of: IVL application at the target site, AND DCB inflation at the target site, AND Residual in-segment diameter stenosis <40% by quantitative coronary angiography, in the absence of final serious angiographic complications (≥ Grade D dissection, perforation, abrupt closure, final TIMI flow ≤ II), AND Without the need for bailout scoring/cutting balloon or atherectomy-based strategy, AND Without the need for bailout stenting. TLF will be defined as a composite of clinically driven revascularization, OR myocardial infarction, OR cardiac death related to the target lesion. | at 1 month follow-up |