Comparing drug eluting balloons and stents for treating calcified nodules in coronary arteries
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
This study is testing whether drug eluting balloons can work as well as drug eluting stents for treating calcified nodules in the coronary arteries of patients with heart conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 12 sites (Barcelona and 11 other locations) |
| Trial ID | NCT06657833 on ClinicalTrials.gov |
What this trial studies
This international, multicenter trial investigates the effectiveness of drug eluting balloons (DEB) versus drug eluting stents (DES) in patients with calcified nodules in coronary arteries. Patients with stable coronary artery disease or acute coronary syndromes will be randomized to receive either DEB or DES after undergoing intravascular lithotripsy to modify the calcified plaque. The study aims to determine if DEB can provide similar or better outcomes in terms of lumen loss and gain compared to DES at a 6-month follow-up. The trial is designed to address the lack of data on the safety and efficacy of DEB in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stable coronary artery disease or acute coronary syndromes and severe calcified lesions suitable for percutaneous coronary intervention.
Not a fit: Patients with life expectancy less than one year, those with left main stem lesions, or those previously treated with stents or DEB may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option for patients with calcified coronary lesions, potentially improving their outcomes.
How similar studies have performed: While there is some observational data on DEB performance in calcified lesions, this approach is relatively novel and lacks extensive prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. * Cardiogenic Shock or Cardiac arrest at the moment of the index procedure. * Impossibility to maintain double antiplatelet treatment during at least 1 month. * Life expectancy \<1 year. * Index lesion at left main stem. * Aorto-ostial lesion. * Target lesion previously treated with stents or DEB. * High thrombus burden in the target lesion (TIMI thrombus scale≥3).
Where this trial is running
Barcelona and 11 other locations
- Hospital Del Mar — Barcelona, Spain (Recruiting)
- Hospital Universitario de La Paz — Fuencarral-El Pardo, Spain (Recruiting)
- Hospital Universitario de Galdakao-Usansolo — Galdakao, Spain (Recruiting)
- Hospital Universitario de León — León, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Madrid, Spain (Recruiting)
- Hospital Clínico San Carlos — Moncloa-Aravaca, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
- Hospital General Universitario de Valencia — Valencia, Spain (Recruiting)
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
- Hospital Universitario de Vigo — Vigo, Spain (Recruiting)
Study contacts
- Study coordinator: Fundacion Epic
- Email: iepic@fundacionepic.org
- Phone: 0034987225638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.