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

Hypertension, Renovascular Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05858190
• Other study ID #: HS - 2133
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2023
• 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Allergic to contrast medium

• Being pregnant or preparing for pregnancy

• With active cancer.

• Life expectancy < 12 month

• Without informed consent

Related Conditions & MeSH terms

• Hypertension, Renovascular
• Renal Artery Obstruction

Intervention

Procedure:
• Parallel Assignment
intervention group: treated with drug eluting balloon(paclitaxel-coated balloon; Orchid, Acotec Scientific Holdings Limited, Beijing, China); control group :treated with plain old balloon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate	uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass	9 months