A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

Hypertension Clinical Trial

— CONTROL HTN-2  

Official title:

A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02895386
• Other study ID #: US HTN-01
• Status: Terminated
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: ROX Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

Inclusion Criteria:

• Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP = 140 mmHg at screening.

Exclusion Criteria:

• Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Device:
• ROX Coupler
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Other:
• Sham procedure
Sham procedure + continuing current antihypertensive medications.

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Cardiology P.C. Research	Birmingham	Alabama
United States	UAB Division of Cardiovascular Disease	Birmingham	Alabama
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	The MetroHealth System	Cleveland	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Duke University Hospital	Durham	North Carolina
United States	The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida
United States	Northwell Health - North Shore University Hospital	Manhasset	New York
United States	Northwell Health - Lenox Hill Hospital	New York	New York
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Cardiology Associates Research	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
ROX Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lobo MD, Ott C, Sobotka PA, Saxena M, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Schmieder RE. Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial. Hypertension. 2017 Dec;70(6):1099-1105. doi: 10.1161/HYPERTENSIONAHA.117.10142. Epub 2017 Oct 23. — View Citation

Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Ott C, Schmieder RE; ROX CONTROL HTN Investigators. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1634-41. doi: 10.1016/S0140-6736(14)62053-5. Epub 2015 Jan 23. Erratum in: Lancet. 2016 Feb 13;387(10019):648. Lancet. 2015 Apr 25;385(9978):1622. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure	Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline	Baseline, 6 months
Secondary	Change in mean office systolic blood pressure	Change in mean office systolic blood pressure at six months as compared to Baseline	Baseline, 6 months