NCT06657833Recruiting
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- 17 Dec 2024
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT06657833
What you commit to
- Study type: Interventional
- Planned participants: 128
- From 17 Dec 2024 to the primary completion date, 30 Oct 2027
- 15 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Target lesion previously treated with stents or DEB.
Other illness
- Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
Other
- Patients must not meet any criteria
- Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
- Pregnant or breastfeeding patients.
- Impossibility to maintain double antiplatelet treatment during at least 1 month.
- Life expectancy \<1 year.
- Index lesion at left main stem.
- Aorto-ostial lesion.
- High thrombus burden in the target lesion (TIMI thrombus scale≥3).
Who the study is looking for
- 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 calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;
- Lesion to treat in a vessel between 2.5 and 4 mm.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario de La Paz Coordinator of this site? Confirm its status | Fuencarral-El Pardo | Spain | Recruiting |
| Hospital Universitario de Galdakao-Usansolo Coordinator of this site? Confirm its status | Galdakao | Spain | Recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Moncloa-Aravaca | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Hospital Universitario de Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.