Coronary Artery Disease
Conditions
Brief summary
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. Patients will be enrolled in up to 5 investigational sites in Switzerland. The patients will be followed up until discharge or until 7 days, whichever comes first.
Interventions
DEVICEBalloon dilatation
Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.
Sponsors
Biosensors Europe SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorised representative must provide written informed consent prior to any study related procedure. 3. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. 4. Subject must agree to undergo all protocol-required follow-up procedures. 5. Subject must agree not to participate in any other clinical study during hospitalisation for the index procedure. * Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation. 1. De novo or restenotic lesions in native coronary arteries or bypass grafts. 2. A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels. 3. The target lesion(s) must have a diameter stenosis of ≥ 50% by visual estimation or online quantitative coronary angiography (QCA) and may include chronic total occlusions (CTO).
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of treated lesions with device success defined as: | During the interventional procedure | 1. Successful device delivery and 2. Successful inflation and deflation of the balloon and 3. No perforation, flow-limiting dissection or reduction in TIMI flow grade and 4. No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with Individual components of device success defined as: | During the interventional procedure | 1. Successful device delivery 2. Successful inflation and deflation of the balloon 3. No perforation, flow-limiting dissection or reduction in TIMI flow grade 4. No life-threatening arrhythmias (sustained VT, VF) |
| Percentage of patients with Procedural success defined as: | 1 - 7 Days | Device success without major adverse cardiovascular events (MACE) which is a composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) during the index hospitalization. |
| Percentage of patients with Target Lesion Failure (TLF) | 1 - 7 Days | A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the index hospitalization. |
Countries
Switzerland
Outcome results
None listed