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 who have a narrowing (blockage) that has come back inside a previously placed stent (called in-stent restenosis) in a heart artery, where one or two stent layers are present.
• The affected artery must be of a certain size — not too small and not too large (between 2.0 mm and 4.0 mm wide, as estimated by the treating doctor).
• People who have only one serious in-stent restenosis lesion that is being targeted in this trial.
• People who may have one other serious blockage in a different artery, provided that blockage is treated before the main target lesion in this trial.
• The target blockage must be no longer than 26 mm and must be fully coverable by a single specialised balloon used in this trial.
• The target blockage must meet specific severity thresholds — either a visually estimated narrowing of 70% or more (but not completely blocked), OR a narrowing of 50–70% combined with at least one of the following: an abnormal blood flow measurement (FFR, iFR, or RFR), an abnormal stress test, or symptoms linked to that blockage.
• People who have experienced a type of heart attack called NSTEMI or an Acute Coronary Syndrome (ACS) event, where certain enzyme levels measured in the blood are decreasing (confirm with trial site).
• The target blockage must have been successfully prepared with a standard procedure before enrolment, leaving a residual narrowing of 30% or less with normal blood flow.

Who may not be able to join:

• People whose heart pumping function is significantly reduced (left ventricular ejection fraction below 30%) within the past 6 months.
• People who have had a heart procedure (PCI or similar coronary intervention) within the last 30 days.
• People who have another heart procedure (PCI or bypass surgery/CABG) already planned after the trial procedure.
• People who have had a certain type of serious heart attack (STEMI) within the past 72 hours, or people with NSTEMI whose blood enzyme levels are still rising within 12 hours of the procedure.
• People whose target artery has previously been treated for restenosis by any method other than balloon angioplasty alone (the specific rules differ depending on whether one or two stent layers are present — confirm with trial site).
• People whose target blockage is located inside a bypass graft (vein or artery graft) rather than a native heart artery.
• People who have a blood clot present in the target artery.
• People who have another significant blockage (greater than 50% narrowing) located just before or after the target lesion in the same artery.
• People who developed a tear in the artery wall during the preparation procedure that required an additional stent to be placed.
• People whose target in-stent blockage has more than two layers of previously placed stents.
• People who have a serious blockage in the left main coronary artery that is not protected by a bypass graft.

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