Comparing stenting and medication for renal artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yuxi Li, MD
• Email: liyuxi@pku.edu.cn
• Phone: 00861083572283

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.