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FFR-guiderad revaskularisering vid aterosklerotisk njurartärstenos: En randomiserad kontrollerad studie (FARS)

6 november 2026 uppdaterad av: Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

Fraktionell flödesreserv-styrd revaskularisering vid aterosklerotisk njurartärstenos: En randomiserad kontrollerad studie

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kina
      • Beijing, Kina, 100037
        • Rekrytering
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Huvudutredare:
          • Xiongjing Jiang, MD
        • Kontakt:
        • Underutredare:
          • Hui Dong, MD,PhD
      • Chongqing, Kina, 400016
        • Rekrytering
        • Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University
        • Kontakt:
      • Shanghai, Kina, 200025
        • Rekrytering
        • Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Kontakt:
      • Tianjin, Kina, 300192
        • Rekrytering
        • TianJin First Central Hospital
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Rekrytering
        • The First Affiliated Hospital of Sun Yat-sen University
        • Kontakt:
      • Guangzhou, Guangdong, Kina, 510080
        • Rekrytering
        • The First Affiliated Hospital of Guangzhou Medical University
        • Kontakt:
      • Guangzhou, Guangdong, Kina
        • Rekrytering
        • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
        • Kontakt:
        • Kontakt:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150086
        • Rekrytering
        • The Second Affiliated Hospital of Harbin Medical University
        • Kontakt:
        • Kontakt:
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Rekrytering
        • Fuwai Central China Cardiovascular Hospital
        • Kontakt:
      • Zhengzhou, Henan, Kina, 450007
        • Rekrytering
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Kontakt:
      • Zhengzhou, Henan, Kina, 450000
        • Rekrytering
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Kontakt:
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 211800
        • Rekrytering
        • Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)
        • Kontakt:
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330038
        • Rekrytering
        • Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
        • Kontakt:
    • Liaoning
      • Dalian, Liaoning, Kina, 116001
        • Rekrytering
        • Affilated Zhongshan Hospital of Dalian University
        • Kontakt:
      • Dalian, Liaoning, Kina
        • Rekrytering
        • Frist Aiffiliated Hospital of Dalian Medical University
        • Kontakt:
    • Lilin
      • Changchun, Lilin, Kina, 130033
        • Rekrytering
        • China-Japan Union Hospital of Jilin University
        • Kontakt:
    • Shandong
      • Jinan, Shandong, Kina
        • Rekrytering
        • Qilu Hospital of Shandong University
        • Kontakt:
      • Qingdao, Shandong, Kina
        • Rekrytering
        • Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)
        • Kontakt:
    • Sichuan
      • Chengdu, Sichuan, Kina, 610031
        • Rekrytering
        • The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: stent group with FFR ≥ 0.8

Drug-induced hyperemic FFR ≥ 0.80
Enhet: Randomized to stenting

Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
Aktiv komparator: drug group with FFR ≥ 0.8

Drug-induced hyperemic FFR ≥0.80
Läkemedel: Randomized to optimal medical therapy (OMT)

Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.
Övrig: FFR < 0.8

Drug-induced hyperemic FFR ≥0.80
Enhet: stent implantation

Patients with pharmacologically induced renal FFR < 0.80 will receive stent implantatio.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
eGFR changes
Tidsram: From baseline to 12 months post-procedure

The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
From baseline to 12 months post-procedure

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
kardiovaskulär död
Tidsram: Från baslinjen till 12 månader efter ingreppet
Från baslinjen till 12 månader efter ingreppet
Number of Participants with myocardial infarction
Tidsram: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure
Number of Participants with non-fatal stroke
Tidsram: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure
Number of Participants with rehospitalization for congestive heart failure
Tidsram: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure
24h-SBP changes
Tidsram: From baseline to 12 months post-procedure

24-hour average systolic blood pressure
From baseline to 12 months post-procedure
24h-DBP changes
Tidsram: From baseline to 12 months post-procedure

24-hour average diastolic blood pressure
From baseline to 12 months post-procedure
OBP changes
Tidsram: From baseline to 12 months post-procedure

Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline.
From baseline to 12 months post-procedure
medication load changes
Tidsram: From baseline to 12 months post-procedure

Change in antihypertensive medication load at 12 months post-procedure compared to baseline
From baseline to 12 months post-procedure
Rate of stent restenosis
Tidsram: From baseline to 12 months post-procedure

Rate of stent restenosis after stent implantation in patients with atherosclerotic renal artery stenosis.
From baseline to 12 months post-procedure
perioperative complications
Tidsram: From baseline to 30 days post-procedure

The perioperative complications for atherosclerotic renal artery stenosis includes: renal artery injury, thrombosis, restenosis, infection, aortic dissection.
From baseline to 30 days post-procedure
Vascular Complications
Tidsram: From baseline to 12 months post-procedure

Incidence of Vascular complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention.
From baseline to 12 months post-procedure
renal adverse events
Tidsram: From baseline to 12 months post-procedure

Renal adverse events after surgery in patients with atherosclerotic renal artery stenosis may include acute kidney injury, progressive renal dysfunction, and the need for renal replacement therapy such as dialysis.
From baseline to 12 months post-procedure
Rate of Renal Target Organ Damage
Tidsram: From baseline to 12 months post-procedure

sustained eGFR decline, CKD stage progression, new-onset overt proteinuria, kidney atrophy progression, initiation of kidney replacement therapy, or kidney-related hospitalization
From baseline to 12 months post-procedure
RBR
Tidsram: From baseline to 12 months post-procedure

risk-benefit ratio
From baseline to 12 months post-procedure
all-cause death
Tidsram: From baseline to 12 months post-procedure

Occurrence of death from any cause during the study period
From baseline to 12 months post-procedure
UACR changes
Tidsram: From baseline to 12 months post-procedure

urinary microalbumin-to-creatinine ratio (UACR)
From baseline to 12 months post-procedure

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 maj 2026

Primärt slutförande (Beräknad)

31 maj 2027

Avslutad studie (Beräknad)

31 mars 2028

Studieregistreringsdatum

Först inskickad

30 mars 2026

Först inskickad som uppfyllde QC-kriterierna

30 mars 2026

Första postat (Faktisk)

6 april 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2026-3057

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