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
Parallel
Renal denervation
DeviceCatheter-based renal denervation performed during a standard renal artery catheterization procedure using a dedicated renal denervation system, according to the study protocol. The procedure is performed in addition to ongoing antihypertensive medical therapy, which is continued throughout the study as clinically indicated.
Primary endpoint: Win Ratio of Hierarchical Composite Endpoint After Staged PCI
The primary endpoint will be assessed using a win ratio, a statistical method that compares treatment groups based on a hierarchical evaluation of clinically ordered outcomes. Patients will be compared pairwise between treatment groups, and outcomes will be evaluated in the following predefined order of clinical importance after staged PCI: Cardiovascular death Stroke Myocardial infarction Number of hospitalizations for heart failure Hospitalization for hypertensive crisis (yes/no) Number of hypertensive emergencies Change in office systolic blood pressure Change in antihypertensive medication (increase, no change, or decrease in number and/or dosage) For each patient pair, the first outcome in the hierarchy that differs between patients will determine the winner. The win ratio will be calculated as the total number of wins in the investigational treatment group divided by the total number of wins in the control group.
Primary safety endpoint : Major vascular access site complications
Number of participants who experience Major vascular access site complications within 30 d after the staged PCI.
Primary safety endpoint: Contrast-associated acute kidney injury (CA-AKI) (≥25% increase in serum creatinine within 48-72 hours)
Number of patient having ≥25% increase in serum creatinine within 48-72 hours after the procedure
Primary safety endpoint: Renal artery complications
Number of patients with renal artery complications (dissection requiring intervention) and renal artery stenosis (requiring intervention)
Secondary endpoint
\- ambulatory blood pressure change (increase - no change or decrease) between groups
Secondary endpoints: Quality of life
improvement of QoL (EQ-5D-5L)
Secondary endpoints: Health economics
Incremental Cost-Effectiveness Ratio (enal denervation plus standard of care versus standard of care alone)
Secondary endpoint: Time to first hypertension emergency
A hypertensive crisis is defined by 2018 ESC/ESH Guidelines as a unplanned hospitalization due to severe elevation in blood pressure, typically ≥ 180 mmHg systolic and/or ≥ 120 mmHg diastolic, encompassing both hypertensive emergencies and hypertensive urgencies.
This trial is not recruiting at the moment. You can still explore other options:
