Hypertension, RenovascularNCT05858190
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
A study testing Parallel Assignment in people with Hypertension, Renovascular, run by Peking Union Medical College Hospital.
Trial summary
The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect 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?
- Parallel Assignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
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- With severe cardiopulmonary insufficiency.
- Allergic to contrast medium
- Being pregnant or preparing for pregnancy
- With active cancer.
- Life expectancy < 12 month
- Without informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
yuexin chen, MD contact
About this study
Official title: Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study
The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect of blood pressure control.
- Conditions
- Hypertension, Renovascular
- Being tested
- Parallel Assignment
- Medical subject headings
- Hypertension, Renovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parallel AssignmentProcedure or surgery
intervention group: treated with drug eluting balloon（paclitaxel-coated balloon； Orchid, Acotec Scientific Holdings Limited, Beijing, China)； control group :treated with plain old balloon
| Study group | Role | What they receive |
|---|---|---|
| DEB group | Experimental | paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China) Receives: Procedure: Parallel Assignment |
| POB group | Placebo comparator | Not described Receives: Procedure: Parallel Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858190
- Sponsor's protocol ID
- HS - 2133
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song X, Fu Y, Lai Z, Di X, Zeng R, Shao J, Ni L, Liu Z, Song X, Ye W, Liu C, Liu B, Zheng Y, Chen Y. Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis-a multi-center study. BMC Cardiovasc Disord. 2023 Oct 16;23(1):510. doi: 10.1186/s12872-023-03484-5.
PubMed 37845604
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study
- ClinicalTrials.gov ID
- NCT05858190
- Acronym / sponsor ID
- HS - 2133
- Conditions
- Hypertension, Renovascular
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 May 2023 (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.
The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect 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
| Arm | Type | Receives |
|---|---|---|
| DEB group | Experimental | Procedure: Parallel Assignmentpaclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China) |
| POB group | Placebo comparator | Procedure: Parallel Assignment |
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 (12 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)
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 |
|---|---|---|
| Parallel Assignmentintervention group: treated with drug eluting balloon（paclitaxel-coated balloon； Orchid, Acotec Scientific Holdings Limited, Beijing, China)； control group :treated with plain old balloon | Procedure or surgery | DEB group, POB group |
Primary outcome
Primary patency rate
Time frame: 9 months
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 37845604Song X, Fu Y, Lai Z, Di X, Zeng R, Shao J, Ni L, Liu Z, Song X, Ye W, Liu C, Liu B, Zheng Y, Chen Y. Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis-a multi-center study. BMC Cardiovasc Disord. 2023 Oct 16;23(1):510. doi: 10.1186/s12872-023-03484-5.
- 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.
yuexin chen, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Parallel Assignment in people with Hypertension, Renovascular, run by Peking Union Medical College Hospital.
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 12 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: opening soon, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Primary patency rate (time frame: 9 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 NCT05858190, which also lists 1 linked publication.
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 15 May 2023.