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Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis

NCT06447740 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-16

No results posted yet for this study

Summary

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. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. Based on the primary finding of FAIR-pilot study (NCT05732077), FFR-guided renal artery stenting is practical.

The overall purpose of the FAIR trial is to compare the clinical outcomes and safety of FFR-guided stenting plus optimal medical treatment (OMT) versus OMT alone in patients with renal-vascular hypertensive patients.

With the 'all comers' design, participants met the inclusive/exclusive criteria will be enrolled, and hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, patients will be treated with OMT alone and follow up. If FFR is \<0.80, participants will be randomized to stenting in the renal artery plus OMT or OMT alone on a 1:1 ratio. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.

Conditions

  • Renal Artery Stenosis Atherosclerotic
  • Secondary Hypertension Renal Arterial

Interventions

DRUG

Dopamine

A bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status

DIAGNOSTIC_TEST

Fractional Flow Reserve, Renal

Renal FFR will be measured based on SOP

DEVICE

Renal artery stenting

Renal artery stenting will be implanted based on the protocol

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-06-03
Completion
2027-04-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06447740 on ClinicalTrials.gov