Shockwave IVL + DCB

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.

NCT Number	NCT05625997
Lead Sponsor	Rede Optimus Hospitalar SA
Conditions	Calcified Lesions in Small Coronary Vessels
Enrollment	50 participants
Start Date	2023-06-16
Primary Completion	2025-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-16