Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery diseasE

NCT07602790 | Not Yet Recruiting

• 1 other identifier: EMBRACE
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multivessel Coronary Artery Disease; Hypertension Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  2 Years post procedure

• 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.

  30 days after 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

  30 days after staged PCI

• Primary safety endpoint: Renal artery complications

  Number of patients with renal artery complications (dissection requiring intervention) and renal artery stenosis (requiring intervention)

  30 days after staged PCI

Secondary Outcomes (5)

• Secondary endpoint

  2, 3 & 5 Years after procedure

• Secondary endpoints: Quality of life

  2, 3 & 5 years after staged PCI

• Secondary endpoints: Health economics

  2, 3 & 5 years after staged PCI

• Secondary endpoint: Time to first hypertension emergency

  2, 3 & 5 Years

• Secondary endpoint: kidney function

  2, 3, 5 Years

Study Arms (2)

Renal denervation

EXPERIMENTAL

Renal denervation (patient continue hypertension medication if applicable)

Device: Renal denervation

Control

NO INTERVENTION

Standard of care (patient continue hypertension medication if applicable)

Interventions

Renal denervation DEVICE

Catheter-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.

Renal denervation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study prior to staged procedure

You may not qualify if:

• \- 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
• Known secondary cause (e.g., renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, or other identifiable etiologies).
• Severe renal failure (eGFR \<30 ml/min/1.73 m²)
• Known LVEF \<30%
• Known history of polycystic kidney disease, unilateral kidney, or undergone renal transplant
• Mechanical circulatory support during PCI
• Subject is under judicial protection, tutorship or curatorship
• Failure of index procedure
• Acute MI, severe renal failure, need for mechanical circulatory support, or legal incapacity between the index and staged procedures resulting in loss of eligibility.

Sponsors & Collaborators

• Ceric Sàrl: lead

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

• Felix Mahfoud, Prof.

  Departement Biomedizin DBM Hebelstrasse

  PRINCIPAL INVESTIGATOR

• Roxana Mehran, Prof.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estelle Darrau, Ph.D

CONTACT

0675657408; edarrau@cerc-europe.org

laure Morsiani, Ph.D

CONTACT

0176739236; lmorsiani@cerc-europe.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2033
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share