Shockwave IVL + DCB
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRede Optimus Hospitalar SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
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.
Disqualifiers
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.
Trial population
Patients with a diminished blood flow in their calcified small coronary vessels
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
at 1 month follow-upSponsors and contacts
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Source ClinicalTrials.gov