Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis

NCT07566065 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0427
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 15

Brief Summary

Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic renal artery stenosis remains limited. This study aims to evaluate whether covered stents are more effective than bare metal stents in patients with atherosclerotic renal artery stenosis. Eligible participants will be randomly assigned to receive either a covered stent or a bare metal stent. Patients will be followed for 12 months to assess Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups. The results of this study may help improve treatment strategies and guide the selection of stent type for patients with this condition.

Conditions

Hypertension; Renal Artery Stenosis; Atherosclerotic Renal Artery Stenosis

Keywords

covered stents; bare metal stents; atherosclerotic renal artery stenosis

Outcome Measures

Primary Outcomes (1)

• Change in eGFR

  Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline

  12 months

Secondary Outcomes (11)

• Change in 24-Hour Ambulatory Systolic Blood Pressure

  12 months

• Change in 24-Hour Ambulatory Diastolic Blood Pressure

  12 months

• Change in Office Systolic Blood Pressure

  12 months

• Change in Office Diastolic Blood Pressure

  12 months

• Change in Home Systolic Blood Pressure

  12 months

Study Arms (2)

bare metal stents group

ACTIVE COMPARATOR

Device: Bare Metal Stent

covered stents group

EXPERIMENTAL

Device: Covered Stent

Interventions

Covered Stent DEVICE

Endovascular implantation of a covered stent in the renal artery

covered stents group

Bare Metal Stent DEVICE

Endovascular implantation of a bare metal stent in the renal artery.

bare metal stents group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Renal artery diameter stenosis ≥60%; 2) Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses; 3) Serum creatinine \< 264 μmol/L (3.0 mg/dL); 4) Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;

You may not qualify if:

• \) Unstable clinical condition rendering the patient intolerant to revascularisation therapy; 2) Urinary protein ≥2+; 3) Contrast medium allergy; 4) Renal artery anatomy unsuitable for revascularisation therapy; 5) Reference vessel diameter \<3.5mm or \>8mm. 6)Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis); 7)Reference vessel diameter \< 3.5 mm or \> 8 mm

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (15)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, 450007, China

Location

Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)

Nanjing, Jiangsu, 211800, China

Location

Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)

Nanchang, Jiangxi, 330038, China

Location

Affilated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

Frist Aiffiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)

Qingdao, Shandong, China

Location

The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu

Chengdu, Sichuan, 610031, China

Location

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037

Beijing, China

Location

Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

The Second Affiliated Hospital of Harbin Medical University, Ha'erbin

Harbin, China

Location

China-Japan Union Hospital of Jilin University, Changchun, Lilin

Jilin, 130033, China

Location

MeSH Terms

Conditions

Hypertension; Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases

Central Study Contacts

Xiongjing Jiang

CONTACT

86-010-88322387; jiangxiongjing@163.com

Hui Dong

CONTACT

86-010-88322385; donghui666@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Cardiology

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (15)