Hypertension, Renovascular
Conditions
Keywords
Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia
Brief 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.
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.
Interventions
DEVICEAngioplasty with paclitaxel eluting balloon
The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon
Angioplasty with plain old balloon
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patients are randomly allocated into intervention and control group. The investigator and outcomes assessor only kwow the random number. The participants will not be told the exact group that they were allocated.
Intervention model description
intervention group: treated with drug eluting balloon control group :treated with plain old balloon
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. age between 18y and 45y. 2. with ≥ 60% stenosis in at least one renal artery. 3. with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg). 4. patients with no severe renal insufficiency (eGFR\>30 ml/min, length of the kidney ≥ 7cm). 5. Good compliance. 6. with informed consent.
Exclusion criteria
1. With apparent atherosclerotic risk factors. 2. With renal intervention or surgery history. 3. With congenital anatomical anomaly. 4. With severe renal insufficiency (length of the target kidney \< 7cm, total eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min) 5. With contraindication for antiplatelet therapy. 6. With severe cardiopulmonary insufficiency. 7. Allergic to contrast medium 8. Being pregnant or preparing for pregnancy 9. With active cancer. 10. Life expectancy \< 12 month 11. Without informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit rate(cure or improvement of hypertension) | 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 | 9 months | uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bail-out stenting rate | during the procedure | Stent implanted after angioplasty for residual stenosis of dissection |
| Clinical benefit rate | 1, 3,6,12 months | — |
| primary patency rate | 6,12 months | — |
| Technical success rate | immediately after intervention | No residual stenosis more than 50% |
| secondary patency rate | 9, 12 months | any procedure that restores patency after occlusion |
| Target lesion revascularization | 9,12 months | 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 |
| Renal function | 6,9,12 months | eGFR (ml/min) |
| complication rate | within 30 days post-intervention | All complications occurring within 30 days or during the same hospitalization as the revascularization procedure |
Countries
China
Contacts
Primary ContactXitao Song, MD
Backup ContactYuexin Chen, MD
Outcome results
None listed