Back to resultsDrug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
Primary Purpose
Hypertension, Renovascular
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parallel Assignment
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Renovascular
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DEB group
POB group
Arm Description
paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China)
Outcomes
Primary Outcome Measures
Primary patency rate
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
Secondary Outcome Measures
Full Information
NCT ID
NCT05858190
First Posted
April 5, 2023
Last Updated
May 4, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05858190
Brief Title
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEB group
Arm Type
Experimental
Arm Description
paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China)
Arm Title
POB group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Parallel Assignment
Intervention Description
intervention group: treated with drug eluting balloon（paclitaxel-coated balloon； Orchid, Acotec Scientific Holdings Limited, Beijing, China)； control group :treated with plain old balloon
Primary Outcome Measure Information:
Title
Primary patency rate
Description
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xitao song, MD
Phone
96-10-69152501
Email
sxitao@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
yuexin chen, MD
Phone
96-10-69152502
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
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