NCT06657833

DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).

Detailed description

Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon	Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
DEVICE	Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent	Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

Timeline

• Start date: 2024-12-17
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2024-10-26
• Last updated: 2026-02-12

Locations

12 sites across 1 country: Spain