Fractional Flow Reserve-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial

Plain English Summary

FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial is a Not Applicable clinical trial sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital studying Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation. This trial tests a new way to decide if patients with narrowed kidney arteries need a stent (a small tube to open the artery) or if medication is enough. It is for adults with atherosclerotic renal artery stenosis (narrowing of kidney arteries due to plaque buildup) who have high blood pressure and specific kidney function. Participants will have a measurement called FFR taken to guide treatment decisions, and will then be randomly assigned to either receive a stent or continue with medication. Alternatives include optimal medical therapy (medications and lifestyle changes) or stenting guided by traditional imaging, but this trial explores a more precise FFR-guided approach. The trial aims to enroll 300 participants.

Official Summary

For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations. Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research. Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR \< 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with a significant narrowing (60% or more) in their kidney arteries. Individuals with high blood pressure that is difficult to control with medication or is very high without medication. Patients with adequate kidney function (serum creatinine below a certain level and residual GFR above 10 mL/min). People who are not in an unstable condition, do not have significant protein in their urine, are not allergic to contrast dye, and have kidney arteries suitable for treatment. This trial is studying Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how well a patient's kidney function, specifically their estimated Glomerular Filtration Rate (eGFR), changes over 12 months, indicating if the chosen treatment helps pres The specific primary outcome measures are: eGFR changes (From baseline to 12 months post-procedure). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it investigates a more precise method (FFR) to guide treatment for atherosclerotic renal artery stenosis, aiming to improve outcomes where current stenting strategies have s This research targets Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation, where improved treatment options are needed.

Investor Insight

This trial addresses a significant unmet need in managing renal artery stenosis, a condition affecting a substantial patient population with hypertension and potential kidney damage, and could influen

Is This Trial Right for Me?

Ask your doctor if your kidney artery narrowing is severe enough to be considered for this trial and what the FFR measurement means for your specific case. Understand that you may be randomly assigned to either receive a stent or continue with medication, and discuss the potential benefits and risks of each. Participation involves regular check-ups and tests over 12 months to monitor kidney function, blood pressure, and the condition of the treated artery. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 300 participants

Interventions

• DEVICE: Randomized to stenting — Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
• DEVICE: stent implantation — Patients with pharmacologically induced renal FFR \< 0.80 will receive stent implantatio.
• DRUG: Randomized to optimal medical therapy (OMT) — Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.

Primary Outcomes

• eGFR changes (From baseline to 12 months post-procedure)

Secondary Outcomes

• 24h-SBP changes (From baseline to 12 months post-procedure)
• 24h-DBP changes (From baseline to 12 months post-procedure)
• OBP changes (From baseline to 12 months post-procedure)
• medication load changes (From baseline to 12 months post-procedure)
• stent restenosis (From baseline to 12 months post-procedure)

Full Eligibility Criteria

Inclusion Criteria:

1. Renal artery diameter stenosis ≥60%;
2. Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses;
3. Serum creatinine \< 264 μmol/L (3.0 mg/dL);
4. Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;

Exclusion Criteria:

1. Unstable clinical condition rendering the patient intolerant to revascularisation therapy;
2. Urinary protein ≥2+;
3. Contrast medium allergy;
4. Renal artery anatomy unsuitable for revascularisation therapy;
5. Reference vessel diameter \<3.5mm or \>8mm.
6. Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis);
7. Reference vessel diameter \< 3.5 mm or \> 8 mm.

Trial Locations

• The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
• Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, Guangdong, China
• The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
• The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
• Fuwai Central China Cardiovascular Hospital, Zhengzhou, Henan, China
• Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
• Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
• Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University), Nanjing, Jiangsu, China
• Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College), Nanchang, Jiangxi, China
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Atherosclerotic Renal Artery Stenosis
• Hypertension
• Chronic Kidney Disease
• Cardiovascular Disease
• Peripheral Artery Disease
• Coronary Artery Disease
• Vascular Stenosis
• Nephrology
• Interventional Cardiology
• Medical Therapy

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