EMBRACE is a randomized, controlled, multicenter clinical study evaluating the effect of renal denervation on clinical adverse events in hypertensive patients undergoing staged percutaneous coronary intervention (PCI) for multivessel coronary artery disease.
Subject with multi-vessel disease
Having successful index PCI and planned staged procedure within 1-6 weeks to complete revascularization
Subjects ≥21 years of age
Office systolic blood pressure at index procedure and/or staged procedure (systolic blood pressure >140 mmHg) while taking 2 or more antihypertensive drugs
- Contraindication for RDN outlined by IFU
Acute MI at time of the staged PCI procedure (AMI at time of the index PCI is allowed)
Subject has undergone prior renal denervation.
Subject has renal artery anatomy that is ineligible for RDN treatment per Symplicity Spyral™ IFU
Ceric Sàrl
Lead sponsor