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Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis (COMBAT)

27. april 2026 oppdatert av: Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents

Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic renal artery stenosis remains limited.

This study aims to evaluate whether covered stents are more effective than bare metal stents in patients with atherosclerotic renal artery stenosis. Eligible participants will be randomly assigned to receive either a covered stent or a bare metal stent. Patients will be followed for 12 months to assess Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.

The results of this study may help improve treatment strategies and guide the selection of stent type for patients with this condition.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
      • Beijing, Kina
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037
        • Ta kontakt med:
      • Chongqing, Kina, 400016
        • Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University
      • Harbin, Kina
        • The Second Affiliated Hospital of Harbin Medical University, Ha'erbin
        • Ta kontakt med:
      • Jilin, Kina, 130033
        • China-Japan Union Hospital of Jilin University, Changchun, Lilin
        • Ta kontakt med:
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • The First Affiliated Hospital of Sun Yat-sen University
        • Ta kontakt med:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Ta kontakt med:
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Fuwai Central China Cardiovascular Hospital
      • Zhengzhou, Henan, Kina, 450007
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Ta kontakt med:
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 211800
        • Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330038
        • Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
    • Liaoning
      • Dalian, Liaoning, Kina, 116001
        • Affilated Zhongshan Hospital of Dalian University
      • Dalian, Liaoning, Kina
        • Frist Aiffiliated Hospital of Dalian Medical University
    • Shandong
      • Jinan, Shandong, Kina, 250012
        • Qilu Hospital of Shandong University
      • Qingdao, Shandong, Kina
        • Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)
    • Sichuan
      • Chengdu, Sichuan, Kina, 610031
        • The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: bare metal stents group
Enhet: Bare Metal Stent
Endovascular implantation of a bare metal stent in the renal artery.
Eksperimentell: covered stents group
Enhet: Covered Stent
Endovascular implantation of a covered stent in the renal artery

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in eGFR
Tidsramme: 12 months
Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in 24-Hour Ambulatory Systolic Blood Pressure
Tidsramme: 12 months
Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline
12 months
Change in 24-Hour Ambulatory Diastolic Blood Pressure
Tidsramme: 12 months
Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline
12 months
Change in Office Systolic Blood Pressure
Tidsramme: 12 months
Change in Office Systolic Blood Pressure Compared With Baseline
12 months
Change in Office Diastolic Blood Pressure
Tidsramme: 12 months
Change in Office Diastolic Blood Pressure Compared With Baseline
12 months
Change in Home Systolic Blood Pressure
Tidsramme: 12 months
Change in Home Systolic Blood Pressure Compared With Baseline
12 months
Change in Home Diastolic Blood Pressure
Tidsramme: 12 months
Change in Home Diastolic Blood Pressure Compared With Baseline
12 months
Change in antihypertensive medication burden
Tidsramme: 12 months
Change in antihypertensive medication burden at 12 months compared with pre-procedure levels
12 months
Stent patency
Tidsramme: 12 months
Stent patency at 12 months
12 months
Incidence of perioperative complications
Tidsramme: 1 month
1 month
MACE
Tidsramme: 12 months
Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure.
12 months
Renal Adverse Events
Tidsramme: 12 months
Renal adverse events include a sustained decline in renal function (≥30% decrease in eGFR from baseline confirmed on repeat measurement), doubling of serum creatinine, initiation of renal replacement therapy (dialysis or kidney transplantation), or progression to end-stage renal disease.
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. april 2026

Primær fullføring (Antatt)

30. april 2027

Studiet fullført (Antatt)

30. april 2028

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

27. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-0427

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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