Actively Recruiting
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Led by Fundación EPIC · Updated on 2026-02-12
128
Participants Needed
12
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with stable coronary artery disease or acute coronary syndromes needing PCI
- Severe coronary lesion with calcified nodule confirmed by optical coherence tomography or intravascular ultrasound
- Lesion located in a vessel between 2.5 and 4 mm in diameter
You will not qualify if you...
- Unable or unwilling to provide informed consent or attend follow-up angiographic visits
- Pregnant or breastfeeding
- Cardiogenic shock or cardiac arrest during the initial procedure
- Unable to maintain double antiplatelet therapy for at least 1 month
- Life expectancy less than 1 year
- Lesion located at the left main stem
- Aorto-ostial lesion
- Target lesion previously treated with stents or drug eluting balloon
- High thrombus burden in the target lesion (TIMI thrombus scale 3 or higher)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Hospital Del Mar
Barcelona, Spain, 08003
Actively Recruiting
2
Hospital Universitario de La Paz
Fuencarral-El Pardo, Spain, 28046
Actively Recruiting
3
Hospital Universitario de Galdakao-Usansolo
Galdakao, Spain, 48960
Actively Recruiting
4
Hospital Universitario de León
León, Spain, 24008
Actively Recruiting
5
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
6
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
Actively Recruiting
7
Hospital Clínico San Carlos
Moncloa-Aravaca, Spain, 28040
Actively Recruiting
8
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
9
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Actively Recruiting
10
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
11
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
12
Hospital Universitario de Vigo
Vigo, Spain, 36312
Actively Recruiting
Research Team
F
FUNDACION EPIC
CONTACT
A
ALFONSO JURADO ROMAN, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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