Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis

N/ANot Yet RecruitingNCT07566065

Chinese Academy of Medical Sciences, Fuwai Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Atherosclerotic Renal Artery Stenosis Hypertension Renal Artery Stenosis

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\) 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; Exclusion Criteria: * 1\) 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

Locations (15)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

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

Nanjing, Jiangsu, China

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

Nanchang, Jiangxi, China

Affilated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Frist Aiffiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

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

Qingdao, Shandong, China

...and 5 more locations

Outcomes

Primary Outcomes

Change in eGFR

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

Time frame: 12 months

Secondary Outcomes

Change in 24-Hour Ambulatory Systolic Blood Pressure

Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline

Time frame: 12 months

Change in 24-Hour Ambulatory Diastolic Blood Pressure

Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline

Time frame: 12 months

Change in Office Systolic Blood Pressure

Change in Office Systolic Blood Pressure Compared With Baseline

Time frame: 12 months

Change in Office Diastolic Blood Pressure

Change in Office Diastolic Blood Pressure Compared With Baseline

Time frame: 12 months

Change in Home Systolic Blood Pressure

Change in Home Systolic Blood Pressure Compared With Baseline

Time frame: 12 months

Change in Home Diastolic Blood Pressure

Change in Home Diastolic Blood Pressure Compared With Baseline

Time frame: 12 months

Change in antihypertensive medication burden

Change in antihypertensive medication burden at 12 months compared with pre-procedure levels

Time frame: 12 months

Stent patency

Stent patency at 12 months

Time frame: 12 months

Incidence of perioperative complications

Time frame: 1 month

MACE

Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure.

Time frame: 12 months

Renal Adverse Events

Renal adverse events include a sustained decline in renal function (≥30% decrease in eGFR from baseline confirmed on repeat measurement), doubling of serum creatinine, initiation of renal replacement therapy (dialysis or kidney transplantation), or progression to end-stage renal disease.

Time frame: 12 months

Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis

Overview

Conditions

Interventions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts