Heart Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 or older who have coronary artery disease and, in their treating doctor's judgment, need treatment of a blockage in a heart artery or heart bypass graft using a specific drug-coated balloon device.
- People who are willing and able to sign a written consent form agreeing to take part in the study.
- People whose treated artery blockage(s) can be fully covered by the balloon device, with the treatment extending at least 3 mm beyond each edge of the affected area.
- People with blockages in more than one heart artery may still be eligible, provided specific conditions about how each vessel and lesion is treated and documented are met (confirm with trial site).
Who may not be able to join:
- People who do not wish to take part in the study.
- People with a known allergy or intolerance to sirolimus (the drug used in the device) or any component of the device.
- People who cannot take antiplatelet medications (blood-thinning medicines that prevent clots).
- People whose life expectancy is less than 12 months.
- People whose condition requires open heart surgery to treat their coronary artery disease rather than a catheter-based procedure.
- People who are pregnant or breastfeeding.
- People whose doctor considers them unsuitable for a drug-coated balloon, including those with bleeding disorders, stomach ulcers, or certain brain or blood vessel conditions affecting the use of antiplatelet therapy.
- People experiencing cardiogenic shock (a serious condition where the heart cannot pump enough blood to the body).
- People with very poor heart pumping function (left ventricular ejection fraction below 30%) unless a mechanical heart support device is used during the procedure.
- People whose target artery is smaller than 2.00 mm or larger than 4.0 mm in diameter.
- People who need treatment of the left main coronary artery (a major heart artery).
- People whose blockage cannot be treated using a catheter-based procedure.
- People who have coronary artery spasm without a significant actual blockage.
- People whose blockage has certain features making it unsuitable for treatment with a drug-coated balloon alone, including blockages at the point where the artery meets the aorta, blockages with visible blood clot remaining after attempted removal, or blockages being treated shortly after a heart attack where there is evidence of clot or reduced blood flow (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Víctor A Jiménez Díaz, MD, MPH, Hospital Álvaro Cunqueiro, Vigo. SERGAS
Phone: +34986825564
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Target Lesion Failure (TLF)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.