NCT05625997

Shockwave IVL + DCB

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Rede Optimus Hospitalar SA · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Calcified Lesions in Small Coronary Vessels

Timeline

• Start date: 2023-06-16
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2022-11-23
• Last updated: 2025-05-16

Locations

2 sites across 2 countries: Brazil, Italy