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

27. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse 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
        • Kontakt:
      • 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
        • Kontakt:
      • Jilin, Kina, 130033
        • China-Japan Union Hospital of Jilin University, Changchun, Lilin
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • The First Affiliated Hospital of Sun Yat-sen University
        • Kontakt:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Kontakt:
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Fuwai Central China Cardiovascular Hospital
      • Zhengzhou, Henan, Kina, 450007
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Kontakt:
    • 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
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: bare metal stents group
Enhed: Bare Metal Stent
Endovascular implantation of a bare metal stent in the renal artery.
Eksperimentel: covered stents group
Enhed: Covered Stent
Endovascular implantation of a covered stent in the renal artery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. april 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. april 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0427

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

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Ingen

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