Trial comparing treatments for Renal Artery Stenosis Atherosclerotic
Official title Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
ClinicalTrials.gov ID: NCT06447740
What this study is testing
What is Dopamine?
Dopamine is an investigational medicine, given as an once-daily, being studied as a potential treatment for renal artery stenosis atherosclerotic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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;
- 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 treatment therapy 30 days prior to study entry;
See the full eligibility criteria
- 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.
- 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;
- 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 treatment therapy 30 days prior to study entry;
- LVEF \<30%;
- Comorbidity 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 \ 8 mm.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.