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New treatment option for Coronary Artery Disease
Official title DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
ClinicalTrials.gov ID: NCT06657833
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all
- Patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention...
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Patients must meet all
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Fuencarral-El Pardo, Spain
- Galdakao, Spain
- León, Spain
- Madrid, Spain
- Moncloa-Aravaca, Spain
- Pamplona, Spain
- Valencia, Spain
- Valladolid, Spain
- Vigo, Spain
- Zaragoza, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Fuencarral-El Pardo, Spain; Galdakao, Spain; León, Spain; Madrid, Spain; Moncloa-Aravaca, Spain and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.