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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension, Renovascular
• Intervention / Treatment: Device: Angioplasty with paclitaxel eluting balloon; Device: Angioplasty with plain old balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xitao song, MD; Phone Number: 96-10-69152501; Email: sxitao@sina.com
• Study Contact Backup: Name: Yuexin Chen, MD; Phone Number: 96-10-69152502; Email: cyuexin2007@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xitao Song, MD; Phone Number: 96-10-69152502; Email: sxitao@sina.com
      • Contact: Yuexin Chen, MD; Phone Number: 96-10-69152501; Email: cyuexin2007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	No residual stenosis more than 50%	immediately after intervention
complication rate	All complications occurring within 30 days or during the same hospitalization as the revascularization procedure	within 30 days post-intervention
Bail-out stenting rate	Stent implanted after angioplasty for residual stenosis of dissection	during the procedure
Clinical benefit rate		1, 3,6,12 months
primary patency rate		6,12 months
Renal function	eGFR (ml/min)	6,9,12 months
Renal function	serum Cr	6,9,12 months
secondary patency rate	any procedure that restores patency after occlusion	9, 12 months
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	9,12 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Yuehong Zheng, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Takayasu Arteritis; Fibromuscular Dysplasia; Renal Artery Obstruction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Hypertension; Hypertension, Renal; Renal Artery Obstruction; Hypertension, Renovascular; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• 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
• product manufactured in and exported from the U.S.: No