DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Patients must meet all inclusion criteria:
• Patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
• Severe coronary lesion with a calcified nodule (highly recommended confirmation with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and
• Lesion to treat in a vessel between 2.5 and 4 mm
Locations
Other Locations
Spain
Hospital Del Mar
RECRUITING
Barcelona
Hospital Universitario de La Paz
RECRUITING
Fuencarral-el Pardo
Hospital Universitario de Galdakao-Usansolo
RECRUITING
Galdakao
Hospital Universitario de León
RECRUITING
León
Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario de Vigo
RECRUITING
Vigo
Contact Information
Primary
FUNDACION EPIC
iepic@fundacionepic.org
0034987225638
Backup
ALFONSO JURADO ROMAN, MD,PhD
alfonsojuradoroman@gmail.com
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 128
Treatments
Other: Drug Eluting Balloon (DEB)
Other: Drug Eluting Stent (DES)
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC