NCT06447740Recruiting
Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Plus Optimal Medical Therapy Versus Optimal Medical Therapy Alone In Atherosclerosis Renal-vascular Hypertension Patients: a Multicenter Randomized Trial
Source: ClinicalTrials.gov · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. One important gap is that there is no universal standard to determine whether to stent in these patients. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. Based on the primary finding of FAIR-pilot study (NCT05732077), FFR-guided renal artery stenting is practical. The overall purpose of the FAIR trial is to compare the clinical outcomes and safety of FFR-guided stenting plus optimal medical treatment (OMT) versus OMT alone in patients with renal-vascular hypertensive patients. With the 'all comers' design, participants met the inclusive/exclusive criteria will be enrolled, and hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, patients will be treated with OMT alone and follow up. If FFR is \<0.80, participants will be randomized to stenting in the renal artery plus OMT or OMT alone on a 1:1 ratio. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 2 Jun 2024
- Start date
- 3 Jun 2024
- Primary completion date
- 3 Jun 2026
- Lead sponsor
- Peking University First Hospital
- Diseases
- High blood pressure
- NCT number
- NCT06447740
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 3 Jun 2024 to the primary completion date, 3 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any drug or device trial during the study period;
- Any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry;
- Previous kidney transplant;
- Previous renal artery bypass surgery or stent intervention;
Other illness
- Any stroke/TIA, OR with ≥70% stenosis of carotid artery;
- Comorbidity condition causing life expectancy ≤1 year;
- Allergy to contrast or any of the following: aspirin, clopidogrel;
Lab values
- LVEF \<30%;
- Local lab serum Cr \>3.0 mg/dl (265.2μmol/l) on the day of randomization;
Other
- SBP ≥200mmHg and/or DBP ≥120mmHg at the day or randomization;
- Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis;
- Pregnancy or unknown pregnancy status in female of childbearing potential;
- Kidney size less than 8 cm measured by ultrasound;
- Reference vessel size \<4 mm or \>8 mm.
Who the study is looking for
- With recorded hypertension, AND the blood pressure is not controlled (daytime mean SBP ≥135 mmHg and/or DBP ≥85 mmHg based on ABPM) 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.