Comparing drug eluting balloons and stents for treating calcified nodules in coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Leiden University Medical Center
  Leiden, Netherlands Recruiting
• 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 Universitari de Bellvitge
  L'Hospitalet de Llobregat, Spain Recruiting
• Hospital Universitario de León
  León, Spain Recruiting

Study contacts

• Study coordinator: Fundacion Epic
• Email: iepic@fundacionepic.org
• Phone: 0034987225638

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

• Predicting vasopressor needs after anesthesia in elective on-pump CABG using dynamic arterial elastance

  This study tests whether EaDyn measured after induction can help predict which patients will need vasopressors during elective on-pump CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871201

• Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in CABG Patients

  This study tests whether the amount a patient’s pulse pressure varies during surgery relates to how quickly lactate levels drop after CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.