Fractional Flow Reserve to Determine Atherosclerosis Renal Hypertension Stenting (FAIR-Pilot)
Renal Artery Stenosis Atherosclerotic, Secondary Hypertension Renal Arterial
About this trial
This is an interventional diagnostic trial for Renal Artery Stenosis Atherosclerotic
Eligibility Criteria
Inclusion Criteria: With recorded hypertension, AND the blood pressure is not controlled (SBP ≥140mmHg and/or DBP ≥90mmHg) on 2 or more classes of anti-hypertensive drugs; Evidence of renal artery stenosis and undergoing renal artery angiography; Able to follow the study protocol and provide informed consent; Renal artery angiography shows at least 1 main artery with stenosis of 50%-90%, AND the diameter is ≥ 4.0mm. Exclusion Criteria: SBP ≥200mmHg and/or DBP ≥120mmHg at the day or randomization; Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis; Pregnancy or unknow pregnancy status in female of childbearing potential; Participation in any drug or device trial during the study period; Any stroke/TIA, OR with ≥70% stenosis of carotid artery; Any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry; LVEF <30%; Comorbid condition causing life expectancy ≤1 year; Allergy to contrast or any of the following: aspirin, clopidogrel; Previous kidney transplant; Previous renal artery bypass surgery or stent intervention; Kidney size less than 8 cm measured by ultrasound; Local lab serum Cr >3.0 mg/dl (265.2μmol/l) on the day of randomization; Reference vessel size <4 mm or >8 mm.
Sites / Locations
- China-Japan Friendship HospitalRecruiting
- Peking University First HospitalRecruiting
- Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
- Beijing Friendship Hospital, Capital Medical UniversityRecruiting
- The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
- The Second Affiliated Hospital of Soochow UniversityRecruiting
- The Second Affiliated Hospital of Nanchang UniversityRecruiting
- Zibo Central HospitalRecruiting
- Peking University First Hospital Taiyuan HospitalRecruiting
- Tianjin Beichen HospitalRecruiting
- Tianjin First Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
Not stenting
Stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. If FFR is ≥0.80, randomization will be applied, and no stenting will be implanted. If FFR is <0.80, randomization will be ignored, and stenting will be performed.
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.