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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05858190
Other study ID # HS - 2133
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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