Rise Semi Compliant Balloon Study in Patient With CAD

Inclusion criteria

• General Inclusion Criteria

• Subject must be at least 18 years of age.
• Subject or a legally authorised representative must provide written informed consent prior to any study related procedure.
• Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
• Subject must agree to undergo all protocol-required follow-up procedures.
• 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.

• De novo or restenotic lesions in native coronary arteries or bypass grafts.
• A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels.
• 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 Exclusion Criteria

• Planned use of a non-study angioplasty balloon during the procedure for pre-dilatation or dilatation of the lesion.
• Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, other anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-treated.
• Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
• Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study.
• Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
• Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

• Unprotected left main coronary artery disease
• More than two lesions requiring treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one balloon, will be considered as a single lesion.
• Coronary artery spasm in the absence of significant stenosis.
• Anticipated need for plaque modification using rotational/orbital atherectomy or intravascular lithotripsy. Note: The use of scoring or cutting balloons after (pre)-dilatation with the study device is allowed.
• Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure (in-hospital staged PCI).