ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, th
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of case
| Condition(s) | Calcified Atheroma, Coronary Artery Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of cases and is associated with increased rates of major adverse cardiovascular events (MACE). The mechanism of PPMI is thought to be related to side branch occlusion, coronary artery dissection and acute microvascular damage caused by embolization of plaque debris during the PCI and is more frequently seen in calcified coronary artery disease. Calcium modification by rotational atherectomy (RA) results in peri-procedural myocardial infarction in 24% of cases and myocardial injury i |
| Who can participate | Inclusion Criteria: * Patient older than 18 years. * The subject has stable or unstable angina pectoris, or a positive functional study for ischemia. * The subject is eligible for PCI. * The subject gives consent prior to study inclusion. * The subject has a calcified lesion that does not dilated fully after balloon angioplasty at 16atm with a ≥2.5mm non-compliant balloon. * The calcified lesion has a 50-90% diameter stenosis by angiographic assessment. Exclusion Criteria: * Previous and/or planned brachytherapy of target vessel. * Pregnant and/or breast-feeding females or females who intend to become pregnant. * Patients who intend to have a major surgical intervention within 6 months of enrolment in the study. * Patients who previously participated in this study. * Subject has experience |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Leuven, Brabant, Belgium |
| Start date | 2022-02-04 |
| NCT ID | NCT05208749 |
| Official listing | https://clinicaltrials.gov/study/NCT05208749 |