Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People who are able to understand the study and agree in writing to take part (at some sites outside the US, verbal consent may be accepted for people experiencing a certain type of heart attack)
• People who are considered suitable candidates for a heart procedure called percutaneous coronary intervention (PCI), where a blocked artery is opened using a small tube inserted through the skin
• People who are also considered suitable candidates for bypass heart surgery (CABG)
• People who are eligible to take a two-drug blood-thinning treatment called dual antiplatelet therapy (DAPT), as recommended by medical guidelines
• People who have medical evidence of reduced blood flow to the heart, including stable or unstable chest pain (angina), or silent reduced blood flow detected by testing
• People who are willing and able to attend all required follow-up appointments during the study
• People who have exactly one target blockage in a natural (native) coronary artery that is suitable for treatment with the study device, where the blockage is between 36 mm and 44 mm long and the artery is between 2.25 mm and 4.0 mm wide
• People whose target blockage causes a narrowing of 50% or more but less than 100% of the artery, with some blood still flowing through (TIMI flow greater than 1)
• For US sites: People whose target blockage is either new or has returned after previously being treated only with balloon widening (standard PTCA), not with a stent
• For sites outside the US: People whose target blockage may be new, returned, or within a previously placed stent, in a natural coronary artery

Who may not be able to join:

• People at US sites who have had symptoms or heart tracing (ECG) signs of a major type of heart attack (STEMI) within 72 hours before the procedure (note: people with a less severe type of heart attack called NSTEMI who are medically stable may still be considered)
• People who are medically unstable at the time of the procedure
• People who are pregnant, breastfeeding, or plan to become pregnant during the study period
• People with a known allergy to contrast dye that cannot be managed with pre-treatment, or known allergies to certain medications or materials used in the procedure, including aspirin, thienopyridine, both heparin and bivalirudin, cobalt-chromium alloy or its main components (cobalt, chromium, tungsten, nickel), acrylic, fluoropolymers, silicon carbide, PLLA, or sirolimus
• People who have had a procedure to open a blocked heart artery in the target vessel within the past 12 months, or a procedure in any other heart vessel within 72 hours before the study procedure
• People who have plans for any further heart artery procedures or bypass surgery after the study procedure
• People who have planned surgery or dental surgery within 6 months of the procedure, unless the two-drug blood-thinning treatment can be continued throughout that period
• People who have had a stroke or mini-stroke (TIA) within the past 6 months
• People with active bleeding conditions, blood clotting disorders, or any other reason that makes them unsuitable for the two-drug blood-thinning treatment
• People who would refuse a blood transfusion if needed
• People whose heart pumping strength (left ventricular ejection fraction) has been measured at below 30% within the past 6 months or during the procedure
• People who are on dialysis or have significantly reduced kidney function (confirm with trial site for specific blood test values)
• People with abnormally low white blood cell counts or abnormal platelet counts, as measured by blood tests (confirm with trial site for specific values)
• People currently taking oral or intravenous immune-suppressing medication, or who have a known life-limiting immune or autoimmune condition such as HIV or lupus (inhaled steroids and diabetes are permitted)
• People currently receiving or scheduled to receive chemotherapy within 30 days before or after the procedure, or who have an active cancer that is not in remission
• People taking oral blood-thinning medication (anticoagulants) before the procedure, unless a combination of that medication with the two-drug blood-thinning treatment can be safely maintained according to guidelines
• People with a life expectancy of less than one year
• People currently taking part in, or planning to join, another clinical trial involving an experimental device or drug
• People who, in the treating doctor's opinion, would not be able to attend all required follow-up visits
• People whose target blockage is located in a bypass graft (vein or artery), in the left main coronary artery, within 3 mm of the origin of certain major heart arteries (LAD or LCX), or is a complete blockage (100% narrowed)
• For US sites: People whose target blockage is within a previously placed stent (bare metal or drug-eluting)
• People whose target artery is too twisted, angled, or heavily calcified to allow a balloon to be fully inflated during the procedure
• For US sites: People whose target artery shows signs of blood clots on imaging
• For sites outside the US: People whose target artery shows signs of a large blood clot that has not resolved even after clot removal attempts
• People whose target artery has previously been treated with a radiation-based procedure called brachytherapy
• People in whom the pre-widening step of the target blockage was not successful before the study device is used
• People who have a second (non-target) blockage that does not meet the study's specific requirements for size, location, and treatment success (confirm with trial site for full details)

Important: Always verify eligibility with the trial site directly before applying.