An observational study in Calcified Lesions in Small Coronary Vessels, sponsored by Rede Optimus Hospitalar SA. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Rede Optimus Hospitalar SA · Observational
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.
Rede Optimus Hospitalar SA is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a diminished blood flow in their calcified small coronary vessels
Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:
Exclusion Criteria:
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-up
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Rede Optimus Hospitalar SA