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DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Sponsor: Fundación EPIC
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-12-17
Completion Date
2027-10-30
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (12)
Hospital Del Mar
Barcelona, Spain
Hospital Universitario de La Paz
Fuencarral-El Pardo, Spain
Hospital Universitario de Galdakao-Usansolo
Galdakao, Spain
Hospital Universitario de León
León, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Clínico San Carlos
Moncloa-Aravaca, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario de Vigo
Vigo, Spain