Health TrialsbyHealthPanel

Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis

ConditionsAtherosclerotic Renal Artery StenosisHypertensionRenal Artery Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Covered Stent

    Device

    Endovascular implantation of a covered stent in the renal artery

  • Bare Metal Stent

    Device

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: bare metal stents groupActive comparator 1 intervention
Group B: covered stents groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in eGFR

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

Time frame
12 months

Secondary outcomes

1

Change in 24-Hour Ambulatory Systolic Blood Pressure

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

Time frame
12 months
2

Change in 24-Hour Ambulatory Diastolic Blood Pressure

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

Time frame
12 months
3

Change in Office Systolic Blood Pressure

Change in Office Systolic Blood Pressure Compared With Baseline

Time frame
12 months
4

Change in Office Diastolic Blood Pressure

Change in Office Diastolic Blood Pressure Compared With Baseline

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: