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
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