Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis

Hypertension, Renovascular Clinical Trial

Official title:

Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366596
• Other study ID #: HS-2133
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2019
• Source: Peking Union Medical College Hospital
• Contact: Xitao Song, MD
• Phone: 96-10-69152501
• Email: sxitao[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension, Renovascular
• Renal Artery Obstruction

Intervention

Device:
• Angioplasty with paclitaxel eluting balloon
The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon
• Angioplasty with plain old balloon
Angioplasty with plain old balloon

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 months
Primary	Primary patency rate	uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass	9 months
Secondary	Technical success rate	No residual stenosis more than 50%	immediately after intervention
Secondary	complication rate	All complications occurring within 30 days or during the same hospitalization as the revascularization procedure	within 30 days post-intervention
Secondary	Bail-out stenting rate	Stent implanted after angioplasty for residual stenosis of dissection	during the procedure
Secondary	Clinical benefit rate		1, 3,6,12 months
Secondary	primary patency rate		6,12 months
Secondary	Renal function	eGFR (ml/min)	6,9,12 months
Secondary	Renal function	serum Cr	6,9,12 months
Secondary	secondary patency rate	any procedure that restores patency after occlusion	9, 12 months
Secondary	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	9,12 months