Trials / Not Yet Recruiting
Not Yet RecruitingNCT07511309
FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial
Fractional Flow Reserve-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Atherosclerotic Renal Artery Stenosis
- Fractional Flow Reserve
- Optimal Medical Therapy
- Stent Implantation
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-03-31
- Primary completion
- 2027-05-31
- Completion
- 2028-03-31
- First posted
- 2026-04-06
- Last updated
- 2026-04-06
Locations
20 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07511309. Inclusion in this directory is not an endorsement.