Medication-resistant HypertensionREDUCE-HTN-CNNCT02027012
Treatment of Resistant Hypertension by Renal Denervation in China
A study testing Percutaneous renal denervation with the Vessix™ Renal Denervation System in people with Medication-resistant Hypertension, run by Boston Scientific Corporation at 1 site in China.
Trial summary
REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for the treatment of medication resistant hypertension… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Medication-resistant Hypertension
- What is being tested?
- Percutaneous renal denervation with the Vessix™ Renal Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Sep 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided written informed consent
- Are ≥ 18 years and ≤ 75 years of age
- Have a SBP /DBP ≥ 160/90 mm Hg based on an average of three office-based blood pressure readings (seated) measured according to the protocol (≥ 150 mmHg in subjects with Type 2 diabetes)
- On a stable medication regimen with ≥ 3 anti-hypertensive drugs (one of medications should be a diuretic, unless subject has a documented intolerance to diuretics) at maximally tolerated doses and have had no changes to the medication regimen two (2) weeks prior to enrollment
- With a eGFR ≥ 40 ml/min per 1.73m²
- Are willing and able to comply with all study procedures
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- With a main renal artery diameter of ≥ 3.5 mm and ≤ 7.0 mm for each of their kidneys
- With a main renal artery without significant stenosis (stenosis defined as < 30%)
- With a renal artery length of ≥ 15 mm
Who cannot join
- With secondary hypertension
- With Type I Diabetes Mellitus
- Are contraindicated for intravascular contrast material
- Are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure
- With known bleeding or hyper-coagulation disorders
- Have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
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- Have planned percutaneous vascular or surgical intervention for any reason within the next 6 months
- Have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
- Have an implantable cardioverter defibrillator (ICD) or pacemaker or with a clinically significant abnormal electrocardiogram at time of screening
- Have any serious medical condition, which in the opinion of the investigator, may adversely affect subject safety or the efficacy of the procedure in the study (i.e., subjects with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders)
- Are pregnant, nursing or planning to become pregnant or who are currently taking estrogen or any estrogen-like compound (female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to the procedure)
- Have a known, unresolved history of drug use or alcohol abuse/dependency
- Are currently enrolled in any investigational study wherein subject participation has not been completed
- For any reason, may not be able to understand or comply with instructions
- With only one kidney
- With prior renal denervation procedure
- With prior intervention to right or left renal artery
- With renal artery stenosis as defined by ≥ 30% stenosis confirmed by angiography with two (2) orthogonal views with selective catheterization
- With iliac stenosis requiring intervention at time of procedure and/or within the next six (6) months
- With severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure
- The physician is unable to cannulate the renal artery
- The physician is unable to access the femoral artery by percutaneous means
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hosptial of Qingqing Medical Unversity
Chongqing, Chongqing Municipality, 400010
About this study
Official title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter in China
REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for the treatment of medication resistant hypertension on the basis of the hypothesis that the percutaneous therapeutic renal denervation for the treatment of medication-resistant hypertension using the Vessix™ Renal Denervation System will reduce systolic (SBP) and diastolic blood pressure (DBP) at 6- month compared to baseline as accessed by office-based blood pressure measurements.
Read the detailed description
The Vessix System is a highly-differentiated and advanced renal denervation system that features an intuitive push-button interface, a short 30-second treatment time and an over-the-wire, balloon-based approach familiar to most cardiac and vascular specialists. The Vessix System has both CE Mark and TGA approval and is currently available for sale in Europe, the Middle East, Australia, New Zealand and selected markets in Asia. The Vessix System is an investigational device and not available for sale in China. An current analysis of the REDUCE-HTN post market study affirms the device's safety profile and effective treatment for resistant hypertension.
- Conditions
- Medication-resistant Hypertension
- Being tested
- Percutaneous renal denervation with the Vessix™ Renal Denervation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous renal denervation with the Vessix™ Renal Denervation SystemDevice
Also called Vessix Renal Denervation System
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation with Vessix system | Experimental | Not described Receives: Device: Percutaneous renal denervation with the Vessix™ Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean reduction of systolic blood pressure measured by office-based blood pressure assessment
Measured: at 6-month post procedure
Secondary outcomes (1)
Major adverse event (MAE) rate
Major adverse event (MAE) rate is a composite rate including the following events: All-cause death; Renal failure (eGFR <15 ml/min/1.73m2 or need for renal replacement therapy); Significant embolic event resulting in end-organ damage or intervention to prevent it; Renal artery dissection or perforation requiring intervention;Hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications; Vascular complications requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion
Measured: at one month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionSep 2015
Why it stopped: company strategic change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Vessix device
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Huo, MD, Principal investigator, Beijing University No.1 Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027012
- Sponsor's protocol ID
- S6007
- Acronym
- REDUCE-HTN-CN
- Status last verified
- Sep 2020
- First submitted
- 1 Jan 2014
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter in China
- ClinicalTrials.gov ID
- NCT02027012
- Acronym / sponsor ID
- REDUCE-HTN-CN / S6007
- Conditions
- Medication-resistant Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company strategic change
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Jan 2014 (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.
REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for the treatment of medication resistant hypertension on the basis of the hypothesis that the percutaneous therapeutic renal denervation for the treatment of medication-resistant hypertension using the Vessix™ Renal Denervation System will reduce systolic (SBP) and diastolic blood pressure (DBP) at 6- month compared to baseline as accessed by office-based blood pressure measurements.
Detailed description
The Vessix System is a highly-differentiated and advanced renal denervation system that features an intuitive push-button interface, a short 30-second treatment time and an over-the-wire, balloon-based approach familiar to most cardiac and vascular specialists. The Vessix System has both CE Mark and TGA approval and is currently available for sale in Europe, the Middle East, Australia, New Zealand and selected markets in Asia. The Vessix System is an investigational device and not available for sale in China. An current analysis of the REDUCE-HTN post market study affirms the device's safety profile and effective treatment for resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vessix device
| Arm | Type | Receives |
|---|---|---|
| Renal denervation with Vessix system | Experimental | Device: Percutaneous renal denervation with the Vessix™ Renal Denervation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have provided written informed consent
- Are ≥ 18 years and ≤ 75 years of age
- Have a SBP /DBP ≥ 160/90 mm Hg based on an average of three office-based blood pressure readings (seated) measured according to the protocol (≥ 150 mmHg in subjects with Type 2 diabetes)
- On a stable medication regimen with ≥ 3 anti-hypertensive drugs (one of medications should be a diuretic, unless subject has a documented intolerance to diuretics) at maximally tolerated doses and have had no changes to the medication regimen two (2) weeks prior to enrollment
- With a eGFR ≥ 40 ml/min per 1.73m²
Key exclusion criteria (22 listed)
- With secondary hypertension
- With Type I Diabetes Mellitus
- Are contraindicated for intravascular contrast material
- Are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure
- With known bleeding or hyper-coagulation disorders
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 |
|---|---|---|
| Percutaneous renal denervation with the Vessix™ Renal Denervation SystemAlso: Vessix Renal Denervation System | Device | Renal denervation with Vessix system |
Primary outcome
The mean reduction of systolic blood pressure measured by office-based blood pressure assessment
Time frame: at 6-month post procedure
1 secondary outcome
Major adverse event (MAE) rate
Time frame: at one month post procedure
Results and safety
The study was stopped early (reason given: company strategic change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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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.
Yong Huo, MD principal investigator
Beijing University No.1 Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous renal denervation with the Vessix™ Renal Denervation System in people with Medication-resistant Hypertension, run by Boston Scientific Corporation at 1 site in China.
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 9 inclusion and 22 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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 strategic change). 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?
The mean reduction of systolic blood pressure measured by office-based blood pressure assessment (time frame: at 6-month post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2020.