Comparing stenting and medication for 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

This study is testing whether a specific type of kidney artery stenting combined with the best medication can help people with narrowed kidney arteries and high blood pressure feel better compared to just using medication alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06447740 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness and safety of Fractional Flow Reserve (FFR)-guided renal artery stenting combined with optimal medical treatment versus optimal medical treatment alone in patients with atherosclerotic renal artery stenosis and secondary hypertension. The study addresses the gap in determining which patients may benefit from stenting, as previous trials have shown mixed results. By utilizing FFR, which has proven beneficial in coronary heart disease, the trial seeks to provide a more tailored approach to treatment. Participants will be monitored for clinical outcomes and safety throughout the study.

Who should consider this trial

Good fit: Ideal candidates are patients with uncontrolled hypertension despite treatment and evidence of significant renal artery stenosis.

Not a fit: Patients with non-atherosclerotic renal artery stenosis or those with severely uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of hypertension and renal function in patients with renal artery stenosis.

How similar studies have performed: Previous studies have shown that FFR-guided interventions can be more effective than traditional methods in coronary artery disease, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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 interventional 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 \<4 mm or \>8 mm.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yuxi Li, MD

Conditions Renal Artery Stenosis Atherosclerotic; Secondary Hypertension Renal Arterial