Heart Disease Trial, Recruiting

Written by an AI model from the 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 who are at least 18 years old.
• People (or their legal guardian) who understand what the trial involves and have given written consent before any trial procedures begin.
• People whose heart condition makes them suitable for a procedure called percutaneous coronary intervention (PCI), where a blocked artery is opened using a small tube inserted through the skin.
• People who are willing to attend all required follow-up appointments after the procedure.
• Women who could become pregnant must agree to use a reliable form of contraception from the time of screening until 12 months after the procedure.
• The blocked area being treated must be a new blockage in a natural coronary artery (not a previously treated or bypass-grafted artery).
• The blockage must be greater than 50% but not fully closed, in people with symptoms (or greater than 70% but not fully closed, in people without symptoms), before the artery is prepared for treatment.
• The blocked area must be successfully prepared (opened slightly) before the main treatment is applied.
• If another artery blockage is also being treated during the same procedure, it must be treated first and the result must be considered successful.

Who may not be able to join:

• People with a serious illness (such as cancer or severe heart failure) that may mean they are not expected to live for at least another 12 months.
• People currently struggling with substance abuse, such as alcohol, cocaine, or heroin.
• People who have another planned medical procedure that could interfere with following the trial's requirements or make the results difficult to interpret.
• People currently participating in another clinical trial of an investigational drug or device that has not yet reached its main study goal.
• People who plan to join another investigational drug or device trial within 12 months after the procedure.
• Women who are pregnant or breastfeeding. A pregnancy test is required within 7 days before the procedure, unless there is no possibility of pregnancy.
• People known to have very poor heart pumping function (the heart pumping less than 30% of its capacity).
• People who have had a PCI or other heart artery procedure within the last 30 days.
• People who have another planned heart artery procedure (PCI or bypass surgery) after the main procedure in this trial.
• People who have had a major heart attack within 72 hours before the procedure (confirm with trial site for specific heart attack types: STEMI or QWMI).
• People currently having a type of heart attack (NSTEMI) with rising cardiac markers, ongoing chest pain, or who are medically unstable.
• People in cardiogenic shock, meaning very low blood pressure requiring medication or devices to support the heart.
• People who have had severe heart failure (classified as NYHA class III or IV) within the 6 months before the procedure.
• People considered unable to safely tolerate the artery being briefly blocked for at least 30 seconds during the procedure.
• People with a known allergy to paclitaxel (a drug used in some medical devices) or other components of the devices used in this trial.
• People with a known severe allergy to contrast dye (used during the procedure to see the arteries) that the treating doctor does not consider manageable with pre-treatment.
• People who cannot tolerate blood-thinning or anti-clotting medications required for the procedure.
• People with a platelet count that is either too low (below 100,000/mm³, which increases bleeding risk) or too high (above 700,000/mm³).
• People with significant kidney disease or kidney failure requiring dialysis.
• People where the blockage being treated is inside a previously placed stent.
• People where the blockage is located in a bypass graft (a vein or artery used in previous bypass surgery).
• People where the artery is completely blocked, or where there is evidence of a blood clot in the target artery.
• People where the blockage is heavily calcified (hardened) or would require a special procedure to clear the calcium before treatment.
• People with significant disease in the left main coronary artery or who have blockages in all three main heart arteries all requiring treatment.
• People where the blockage is located at the very point where the coronary artery meets the main artery from the heart (the aortic ostium).

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