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

Primary Purpose

Hypertension, Renovascular

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Angioplasty with paclitaxel eluting balloon

Angioplasty with plain old balloon

About this trial

This is an interventional treatment trial for Hypertension, Renovascular focused on measuring Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DEB group

POB group

Arm Description

angioplasty with paclitaxel eluting balloon

Angioplasty with plain old balloon

Outcomes

Primary Outcome Measures

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

Primary patency rate

uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass

Secondary Outcome Measures

Technical success rate

No residual stenosis more than 50%

complication rate

All complications occurring within 30 days or during the same hospitalization as the revascularization procedure

Bail-out stenting rate

Stent implanted after angioplasty for residual stenosis of dissection

Clinical benefit rate

primary patency rate

Renal function

eGFR (ml/min)

Renal function

serum Cr

secondary patency rate

any procedure that restores patency after occlusion

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

Full Information

NCT ID

NCT04366596

First Posted

March 3, 2020

Last Updated

April 27, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04366596

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Renovascular

Keywords

Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

intervention group: treated with drug eluting balloon control group :treated with plain old balloon

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The patients are randomly allocated into intervention and control group. The investigator and outcomes assessor only kwow the random number. The participants will not be told the exact group that they were allocated.

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DEB group

Arm Type

Experimental

Arm Description

angioplasty with paclitaxel eluting balloon

Arm Title

POB group

Arm Type

Placebo Comparator

Arm Description

Angioplasty with plain old balloon

Intervention Type

Device

Intervention Name(s)

Angioplasty with paclitaxel eluting balloon

Intervention Description

The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon

Intervention Type

Device

Intervention Name(s)

Angioplasty with plain old balloon

Intervention Description

Angioplasty with plain old balloon

Primary Outcome Measure Information:

Title

Clinical benefit rate(cure or improvement of hypertension)

Description

Time Frame

9 months

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

Secondary Outcome Measure Information:

Title

Technical success rate

Description

No residual stenosis more than 50%

Time Frame

immediately after intervention

Title

complication rate

Description

All complications occurring within 30 days or during the same hospitalization as the revascularization procedure

Time Frame

within 30 days post-intervention

Title

Bail-out stenting rate

Description

Stent implanted after angioplasty for residual stenosis of dissection

Time Frame

during the procedure

Title

Clinical benefit rate

Time Frame

1, 3,6,12 months

Title

primary patency rate

Time Frame

6,12 months

Title

Renal function

Description

eGFR (ml/min)

Time Frame

6,9,12 months

Title

Renal function

Description

serum Cr

Time Frame

6,9,12 months

Title

secondary patency rate

Description

any procedure that restores patency after occlusion

Time Frame

9, 12 months

Title

Target lesion revascularization

Description

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

Time Frame

9,12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

sxitao@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuexin Chen, MD

Phone

96-10-69152502

cyuexin2007@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuehong Zheng, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xitao Song, MD

Phone

96-10-69152502

sxitao@sina.com

First Name & Middle Initial & Last Name & Degree

Yuexin Chen, MD

Phone

96-10-69152501

cyuexin2007@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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