Hypertension, RenovascularPhase 3NCT04366596
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis
A Phase 3 study testing Angioplasty with paclitaxel eluting balloon and Angioplasty with plain old balloon in people with Hypertension, Renovascular, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hypertension, Renovascular
- What is being tested?
- Angioplasty with paclitaxel eluting balloon and Angioplasty with plain old balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Oct 2023
- Phase
- Phase 3
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18y and 45y.
- with ≥ 60% stenosis in at least one renal artery.
- with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- patients with no severe renal insufficiency (eGFR>30 ml/min, length of the kidney ≥ 7cm).
- Good compliance.
- with informed consent.
Who cannot join
- With apparent atherosclerotic risk factors.
- With renal intervention or surgery history.
- With congenital anatomical anomaly.
- With severe renal insufficiency (length of the target kidney < 7cm, total eGFR<30ml/min, divided eGFR of the target kidney<8 ml/min)
- With contraindication for antiplatelet therapy.
- With severe cardiopulmonary insufficiency.
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- Allergic to contrast medium
- Being pregnant or preparing for pregnancy
- With active cancer.
- Life expectancy < 12 month
- Without informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100037
Xitao Song, MD, 96-10-69152502, sxitao@sina.com
Yuexin Chen, MD, 96-10-69152501, cyuexin2007@163.com
About this study
Official title: Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study
Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.
Read the detailed description
Renal artery stenosis is common cause for hypertension in young people. It could be treated with open surgery or endovascular intervention. Open surgery has relatively high complication rate. Endovascular intervention is micro-invasive but with high restenosis rate. Drug eluting balloon(DEB) has been demonstrated to be effective for preventing restenosis in peripheral arteries. This study aims to test the efficacy of drug eluting balloon for non-atherosclerotic renal artery stenosis. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon. The primary endpoint is efficacy of blood pressure control.
- Conditions
- Hypertension, Renovascular
- Being tested
- Angioplasty with paclitaxel eluting balloon, Angioplasty with plain old balloon
- Keywords
- Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia
- Medical subject headings
- Hypertension, Renovascular, Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty with paclitaxel eluting balloonDevice
The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon
Angioplasty with plain old balloonDevice
Angioplasty with plain old balloon
| Study group | Role | What they receive |
|---|---|---|
| DEB group | Experimental | angioplasty with paclitaxel eluting balloon Receives: Device: Angioplasty with paclitaxel eluting balloon |
| POB group | Placebo comparator | Angioplasty with plain old balloon Receives: Device: Angioplasty with plain old balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate(cure or improvement of hypertension)
Cure: diastolic blood pressure <90 mm Hg and systolic blood pressure <140 mm Hg off antihypertensive medications. Improvement: diastolic blood pressure <90 mm Hg and/or systolic blood pressure <140 mm Hg on the same or reduced number of medications (or reduced number of defined daily doses as described by the World Health Organization ) or a reduction in diastolic blood pressure by at least 15 mm Hg on the same or reduced number of medications
Measured: 9 months
Primary patency rate
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
Measured: 9 months
Secondary outcomes (9)
Technical success rate
No residual stenosis more than 50%
Measured: immediately after intervention
complication rate
All complications occurring within 30 days or during the same hospitalization as the revascularization procedure
Measured: within 30 days post-intervention
Bail-out stenting rate
Stent implanted after angioplasty for residual stenosis of dissection
Measured: during the procedure
Clinical benefit rate
Measured: 1, 3,6,12 months
primary patency rate
Measured: 6,12 months
Renal function
eGFR (ml/min)
Measured: 6,9,12 months
Renal function
serum Cr
Measured: 6,9,12 months
secondary patency rate
any procedure that restores patency after occlusion
Measured: 9, 12 months
Target lesion revascularization
either repeat percutaneous or surgical revascularization for a lesion anywhere within the angioplasty region or the 5-mm borders proximal or distal to angioplasty region
Measured: 9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, RenovascularStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group: treated with drug eluting balloon control group :treated with plain old balloon
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuehong Zheng, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366596
- Sponsor's protocol ID
- HS-2133
- Status last verified
- Sep 2019
- First submitted
- 3 Mar 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04366596
- Acronym / sponsor ID
- HS-2133
- Conditions
- Hypertension, Renovascular
- Keywords
- Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 29 Apr 2020 (actual)
- 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.
Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.
Detailed description
Renal artery stenosis is common cause for hypertension in young people. It could be treated with open surgery or endovascular intervention. Open surgery has relatively high complication rate. Endovascular intervention is micro-invasive but with high restenosis rate. Drug eluting balloon(DEB) has been demonstrated to be effective for preventing restenosis in peripheral arteries. This study aims to test the efficacy of drug eluting balloon for non-atherosclerotic renal artery stenosis. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon. The primary endpoint is efficacy of blood pressure control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention group: treated with drug eluting balloon control group :treated with plain old balloon
| Arm | Type | Receives |
|---|---|---|
| DEB group | Experimental | Device: Angioplasty with paclitaxel eluting balloonangioplasty with paclitaxel eluting balloon |
| POB group | Placebo comparator | Device: Angioplasty with plain old balloonAngioplasty with plain old balloon |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age between 18y and 45y.
- with ≥ 60% stenosis in at least one renal artery.
- with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- patients with no severe renal insufficiency (eGFR>30 ml/min, length of the kidney ≥ 7cm).
- Good compliance.
Key exclusion criteria (11 listed)
- With apparent atherosclerotic risk factors.
- With renal intervention or surgery history.
- With congenital anatomical anomaly.
- With severe renal insufficiency (length of the target kidney < 7cm, total eGFR<30ml/min, divided eGFR of the target kidney<8 ml/min)
- With contraindication for antiplatelet therapy.
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 |
|---|---|---|
| Angioplasty with paclitaxel eluting balloonThe patients will be treated with renal artery angioplasty using paclitaxel eluting balloon | Device | DEB group |
| Angioplasty with plain old balloonAngioplasty with plain old balloon | Device | POB group |
Primary outcome
Clinical benefit rate(cure or improvement of hypertension)
Time frame: 9 months
Cure: diastolic blood pressure <90 mm Hg and systolic blood pressure <140 mm Hg off antihypertensive medications. Improvement: diastolic blood pressure <90 mm Hg and/or systolic blood pressure <140 mm Hg on the same or reduced number of medications (or reduced number of defined daily doses as described by the World Health Organization ) or a reduction in diastolic blood pressure by at least 15 mm Hg on the same or reduced number of medications
Primary patency rate
Time frame: 9 months
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
9 secondary outcomes
Technical success rate
Time frame: immediately after intervention
complication rate
Time frame: within 30 days post-intervention
Bail-out stenting rate
Time frame: during the procedure
Clinical benefit rate
Time frame: 1, 3,6,12 months
primary patency rate
Time frame: 6,12 months
Renal function
Time frame: 6,9,12 months
Renal function
Time frame: 6,9,12 months
secondary patency rate
Time frame: 9, 12 months
Target lesion revascularization
Time frame: 9,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Yuehong Zheng, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angioplasty with paclitaxel eluting balloon and Angioplasty with plain old balloon in people with Hypertension, Renovascular, run by Peking Union Medical College Hospital 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Apr 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xitao Song, MD (96-10-69152501, sxitao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate(cure or improvement of hypertension) (time frame: 9 months). The study lists 2 primary outcomes in all. 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 29 Apr 2020.