Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366596
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Hypertension, Renovascular Device: Angioplasty with paclitaxel eluting balloon Device: Angioplasty with plain old balloon Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intervention group: treated with drug eluting balloon control group :treated with plain old balloon
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: DEB group
angioplasty with paclitaxel eluting balloon
Device: Angioplasty with paclitaxel eluting balloon
The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon

Placebo Comparator: POB group
Angioplasty with plain old balloon
Device: Angioplasty with plain old balloon
Angioplasty with plain old balloon




Primary Outcome Measures :
  1. Clinical benefit rate(cure or improvement of hypertension) [ Time Frame: 9 months ]
    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

  2. Primary patency rate [ Time Frame: 9 months ]
    uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: immediately after intervention ]
    No residual stenosis more than 50%

  2. complication rate [ Time Frame: within 30 days post-intervention ]
    All complications occurring within 30 days or during the same hospitalization as the revascularization procedure

  3. Bail-out stenting rate [ Time Frame: during the procedure ]
    Stent implanted after angioplasty for residual stenosis of dissection

  4. Clinical benefit rate [ Time Frame: 1, 3,6,12 months ]
  5. primary patency rate [ Time Frame: 6,12 months ]
  6. Renal function [ Time Frame: 6,9,12 months ]
    eGFR (ml/min)

  7. Renal function [ Time Frame: 6,9,12 months ]
    serum Cr

  8. secondary patency rate [ Time Frame: 9, 12 months ]
    any procedure that restores patency after occlusion

  9. Target lesion revascularization [ Time Frame: 9,12 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 18y and 45y.
  2. with ≥ 60% stenosis in at least one renal artery.
  3. with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
  4. patients with no severe renal insufficiency (eGFR>30 ml/min, length of the kidney ≥ 7cm).
  5. Good compliance.
  6. with informed consent.

Exclusion Criteria:

  1. With apparent atherosclerotic risk factors.
  2. With renal intervention or surgery history.
  3. With congenital anatomical anomaly.
  4. With severe renal insufficiency (length of the target kidney < 7cm, total eGFR<30ml/min, divided eGFR of the target kidney<8 ml/min)
  5. With contraindication for antiplatelet therapy.
  6. With severe cardiopulmonary insufficiency.
  7. Allergic to contrast medium
  8. Being pregnant or preparing for pregnancy
  9. With active cancer.
  10. Life expectancy < 12 month
  11. Without informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366596


Contacts
Layout table for location contacts
Contact: Xitao Song, MD 96-10-69152501 sxitao@sina.com
Contact: Yuexin Chen, MD 96-10-69152502 cyuexin2007@163.com

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Xitao Song, MD    96-10-69152502    sxitao@sina.com   
Contact: Yuexin Chen, MD    96-10-69152501    cyuexin2007@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Study Chair: Yuehong Zheng, MD Peking Union Medical College Hospital
Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04366596    
Other Study ID Numbers: HS-2133
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Peking Union Medical College Hospital:
Renal Artery Obstruction
Takayasu Arteritis
Fibromuscular Dysplasia
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Artery Obstruction
Hypertension, Renovascular
Hypertension
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Hypertension, Renal
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action