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

May 4, 2023 updated by: Peking Union Medical College Hospital

Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: yuexin chen, MD
  • Phone Number: 96-10-69152502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEB group
paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China)
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
Placebo Comparator: POB group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency rate
Time Frame: 9 months
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS - 2133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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