Using Fractional Flow Reserve to Guide Stenting in Renal Artery Stenosis

Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial

This study is testing if using a special measurement called Fractional Flow Reserve can help doctors decide when stenting is the right choice for patients with narrowed renal arteries and high blood pressure that isn't controlled by medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 13 sites (Beijing, Beijing Municipality and 12 other locations)
• Trial ID: NCT05732077 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Fractional Flow Reserve (FFR) to determine the appropriateness of renal artery stenting in patients with atherosclerotic renal artery stenosis and uncontrolled hypertension. Despite previous studies showing no benefit from stenting in addition to medical therapy, many patients experience improvements in blood pressure and renal function in practice. The trial aims to establish a standard for deciding when stenting is beneficial by assessing FFR measurements during renal artery angiography. The study will include patients with significant renal artery stenosis who are not adequately controlled on multiple antihypertensive medications.

Who should consider this trial

Good fit: Ideal candidates are patients with atherosclerotic renal artery stenosis who have uncontrolled hypertension despite treatment with two or more antihypertensive medications.

Not a fit: Patients with non-atherosclerotic renal artery stenosis, such as those with fibromuscular dysplasia, or those with severely elevated blood pressure at the time of randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with renal artery stenosis and hypertension, potentially improving their blood pressure control and renal function.

How similar studies have performed: Previous studies have shown that FFR-guided interventions in coronary artery disease can lead to better outcomes, suggesting potential for success in this novel application for renal artery stenosis.

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.

Where this trial is running

Beijing, Beijing Municipality and 12 other locations

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Chao-yang hospital, capital medical university — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Qinghai province cardiovascular and cerebrovascular disease specialist hospital — Xining, Qinghai, China (Recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Recruiting)
• Peking University First Hospital Taiyuan Hospital — Taiyuan, Shanxi, China (Recruiting)
• Tianjin Beichen Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Tianjin First Central Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yuxi Li, MD

Conditions Renal Artery Stenosis Atherosclerotic; Secondary Hypertension Renal Arterial