HypertensionCONTROL HTN-2NCT02895386
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
A study testing ROX Coupler in people with Hypertension and High Blood Pressure, run by ROX Medical, Inc. at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Hypertension, High Blood Pressure
- What is being tested?
- ROX Coupler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 13 sitesUnited States
- Study dates
- 22 Mar 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Cardiology P.C. Research
Birmingham, Alabama, 35211
UAB Division of Cardiovascular Disease
Birmingham, Alabama, 35294
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
The MetroHealth System
Cleveland, Ohio, 44109
OhioHealth Research Institute
Columbus, Ohio, 43214
Duke University Hospital
Durham, North Carolina, 27710
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605
Northwell Health - North Shore University Hospital
Manhasset, New York, 11030
Northwell Health - Lenox Hill Hospital
New York, New York, 10075
Prairie Education and Research Cooperative
Springfield, Illinois, 62769
Cardiology Associates Research
Tupelo, Mississippi, 38801
About this study
Official title: A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
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.
- Conditions
- Hypertension, High Blood Pressure
- Being tested
- ROX Coupler, Sham procedure
- Keywords
- Hypertension, High Blood Pressure, Systolic Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Vascular Disease
- Medical subject headings
- Hypertension, Essential Hypertension, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROX CouplerDevice
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
Sham procedureOther
Sham procedure + continuing current antihypertensive medications.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Active comparator | ROX Coupler implantation and continuing antihypertensive medications. Receives: Device: ROX Coupler |
| Control Group B | Sham comparator | Sham procedure and continuing current antihypertensive medications. Receives: Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months
Secondary outcomes (1)
Change in mean office systolic blood pressure
Change in mean office systolic blood pressure at six months as compared to Baseline
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start22 Mar 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Why it stopped: Company/Sponsor has discontinued business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ROX Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895386
- Sponsor's protocol ID
- US HTN-01
- Acronym
- CONTROL HTN-2
- Status last verified
- May 2019
- First submitted
- 6 Sep 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25620016Lobo 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.
PubMed 29061728
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
- ClinicalTrials.gov ID
- NCT02895386
- Acronym / sponsor ID
- CONTROL HTN-2 / US HTN-01
- Conditions
- Hypertension, High Blood Pressure
- Keywords
- Hypertension, High Blood Pressure, Systolic Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Vascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company/Sponsor has discontinued business
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ROX Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Active comparator | Device: ROX CouplerROX Coupler implantation and continuing antihypertensive medications. |
| Control Group B | Sham comparator | Other: Sham procedureSham procedure and continuing current antihypertensive medications. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROX CouplerROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein). | Device | Treatment Group A |
| Sham procedureSham procedure + continuing current antihypertensive medications. | Other | Control Group B |
Primary outcome
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
Time frame: Baseline, 6 months
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline
1 secondary outcome
Change in mean office systolic blood pressure
Time frame: Baseline, 6 months
Results and safety
The study was stopped early (reason given: Company/Sponsor has discontinued business). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 25620016Lobo 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.
- Background: PubMed 29061728Lobo 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.
- Corporate websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROX Coupler in people with Hypertension and High Blood Pressure, run by ROX Medical, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company/Sponsor has discontinued business). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895386, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.