RADIANCE CAP: RADIANCE Continued Access Protocol

• Sponsor: ReCor Medical, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05017935
• Collaborator: (none)
• Enrollment: 300
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 79.9
• Patients Per Site: 42.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Hypertension, Resistant to Conventional Therapy; Vascular Diseases; Cardiovascular Diseases	Device: Renal Denervation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
• Actual Study Start Date: May 4, 2022
• Anticipated Primary Completion Date: Dec 31, 2028
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal Denervation	Device: Renal Denervation; Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [From baseline to 60 months]

2. Change in average daytime ambulatory systolic BP [From baseline to 2 months post procedure]

Secondary Outcome Measures

1. Change in average 24-hr/night-time ambulatory systolic BP [From baseline to 2 months post procedure]

2. Change in average daytime/24-hr/night-time ambulatory systolic BP [From Baseline to Months 6 and 12 post procedure]

3. Change in average office systolic/diastolic BP [From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure]

4. Change in average home systolic/diastolic BP [From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure]

5. Change in average 24-hr/night-time ambulatory diastolic BP [From baseline to Months 2, 6, and 12 post procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent

• Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Exclusion Criteria:

• Renal artery anatomy ineligible for treatment

• Secondary hypertension not including sleep apnea

• Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)

• eGFR <40

• Brachial circumference ≥42 cm

• Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent

• Documented repeat (>1) hospitalization for hypertensive crisis within 3 months prior to consent

• Documented confirmed episode(s) of unstable angina within 3 months prior to consent

• Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea

• Primary pulmonary hypertension

• Night shift workers

• Pregnant, nursing or planning to become pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cardiac and Vascular Institute	Gainesville	Florida	United States	32604
2	SIU Medicine	Springfield	Illinois	United States	62794-9664
3	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
4	The Brigham and Women's Hospital	Boston	Massachusetts	United States	02120
5	Columbia University Medical Center/NYPH	New York	New York	United States	10032
6	Penn Medicine	Philadelphia	Pennsylvania	United States	19104
7	Swedish Health Services	Seattle	Washington	United States	98122

Sponsors and Collaborators

• ReCor Medical, Inc.

Investigators

• Principal Investigator: Naomi Fisher, MD, Brigham and Women's Hospital/Harvard Medical School
• Principal Investigator: Ajay Kirtane, MD, SM, Columbia University Medical Center/NYPH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• ReCor Medical company website

Publications

• Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.

• Responsible Party: ReCor Medical, Inc.
• ClinicalTrials.gov Identifier: NCT05017935
• Other Study ID Numbers: CLN-0932
• First Posted: Aug 24, 2021
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by ReCor Medical, Inc.: Blood Pressure; Uncontrolled Hypertension; Essential Hypertension; Resistant Hypertension; Denervation
• Additional relevant MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases

Study Results

No Results Posted as of Aug 2, 2022