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 75 or older, or people aged 18 or older who have a high risk of bleeding
- People who have just had a successful procedure (called PCI) using a specific medical device called the Essential Pro DCB, treating 1, 2, or 3 heart arteries
- People with stable or unstable heart artery conditions
- People whose treated artery blockages were in vessels of a certain size (between 2.0 and 4.0 mm wide, as estimated visually)
- People who have given their own informed consent to take part, or whose consent was witnessed by an impartial person
Who may not be able to join:
- People who had a stent placed either during this procedure or in the past 6 months
- People with a known allergy or medical reason to avoid aspirin, heparin, clopidogrel, paclitaxel, or contrast dye that cannot be managed with pre-treatment medication
- People who are pregnant at the time of hospitalisation
- People currently taking part in another clinical trial involving an investigational drug or device within the past 30 days (or within a specified timeframe related to that drug)
- People who have had a type of serious heart attack called an ST-elevation myocardial infarction (STEMI)
- People with a life expectancy of less than 12 months
- People whose heart pumping function is severely reduced (below 30%)
- People who have a blood clot visible at the site of the artery being treated
- People whose treated artery has certain complex characteristics, such as: severe calcium build-up in the artery walls, a blockage in the main left heart artery, a fully blocked artery requiring a complex approach, or a blockage located in a bypass graft (confirm with trial site)
- People with a history of asthma triggered by aspirin or similar anti-inflammatory medicines (NSAIDs)
- People with a history of stomach or intestinal perforation, ulcers, or bleeding related to NSAIDs or blood-thinning medications, or a history of bleeding in the brain
- People with current active stomach ulcers
- People with bleeding disorders or ongoing active bleeding
- People with severely reduced kidney function
- People with severely reduced liver function, including abnormal liver test results
- People with severe heart failure (classified as NYHA grade III or IV)
- People taking a medication called methotrexate at doses of 15 mg per week or more
- People with a low white blood cell count at the start of the trial
- People who are breastfeeding
- People with a severe overactive thyroid condition
- People considered to have a very high risk of blood clots
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
Phone: 216-296-9747
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
Rate of Net Adverse Clinical Events (NACE) at 12 months
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.