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A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

3. oktober 2022 oppdatert av: Micro Medical Solution, Inc.
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

177

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35243
        • Rekruttering
        • Cardiovascular Associates of the Southeast
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jan Skowronski, MD
    • Arizona
      • Mesa, Arizona, Forente stater, 85203
        • Rekruttering
        • Modern Vascular
        • Ta kontakt med:
        • Hovedetterforsker:
          • Scott Brannan, MD
    • California
      • Saint Helena, California, Forente stater, 94574
        • Rekruttering
        • St. Helena Hospital
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Aktiv, ikke rekrutterende
        • Rocky Mountain Regional VA Medical Center
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33312
        • Rekruttering
        • Palm Vascular
        • Hovedetterforsker:
          • Robert Beasley, MD
      • Jacksonville, Florida, Forente stater, 32256
        • Rekruttering
        • First Coast Cardiovascular Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Vaquar Ali, MD
      • Leesburg, Florida, Forente stater, 34748
      • Miami Beach, Florida, Forente stater, 33140
        • Aktiv, ikke rekrutterende
        • Mount Sinai Medical Center
      • Sebring, Florida, Forente stater, 33872
        • Aktiv, ikke rekrutterende
        • Advent Health Sebring
    • Iowa
      • Davenport, Iowa, Forente stater, 52807
        • Rekruttering
        • Vascular Institute of the Midwest
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eric Dippel, MD
    • Louisiana
      • Houma, Louisiana, Forente stater, 70360
        • Rekruttering
        • Cardiovascular Institute of the South
        • Ta kontakt med:
        • Hovedetterforsker:
          • Craig Walker, MD
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Rekruttering
        • University of Maryland - Baltimore
        • Ta kontakt med:
        • Hovedetterforsker:
          • Khanjan Nagarsheth, MD
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49525
        • Rekruttering
        • Advanced Cardiac and Vascular Amputation Prevention Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Fadi Saab, MD
      • Roseville, Michigan, Forente stater, 48066
        • Aktiv, ikke rekrutterende
        • Eastlake Cardiovascular
    • New Jersey
      • Browns Mills, New Jersey, Forente stater, 08015
        • Aktiv, ikke rekrutterende
        • Deborah Heart and Lung Center
      • Clifton, New Jersey, Forente stater, 07013
        • Aktiv, ikke rekrutterende
        • North Jersey Vascular Center
      • Galloway, New Jersey, Forente stater, 08205
        • Rekruttering
        • AMI Vascular Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nicholas Petruzzi, MD
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27607
        • Tilbaketrukket
        • NC Heart and Vascular Research
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Forente stater, 15025
        • Rekruttering
        • US Cardiovascular
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gennady Geskin, MD
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02904
        • Rekruttering
        • Brown University
        • Hovedetterforsker:
          • Peter Soukas, MD
    • South Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
        • Rekruttering
        • Cardiology Consultants
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brian Brown, MD
    • Texas
      • Austin, Texas, Forente stater, 78756
        • Rekruttering
        • Cardiothoracic and Vascular Surgeons
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Nation, MD
      • Tyler, Texas, Forente stater, 75701
        • Tilbaketrukket
        • Cardiovascular Associates of East Texas
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53221
        • Rekruttering
        • AZH/WAVE Vascular Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Awais Siddique, MD

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

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

General Inclusion Criteria:

  1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
  2. Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-5.
  3. The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent.
  4. Subject is willing to comply with all required follow-up visits.

  5. Subject life expectancy is ≥1 year per the Principal Investigator.

    Angiographic Inclusion Criteria

  6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (<50% stenosis) inframalleolar outflow vessel.
  7. Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries.
  8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
  9. The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.

General Exclusion Criteria:

  1. Subject had a prior or has a planned index limb amputation above the ankle.
  2. Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone.
  3. Subject is pregnant, plans to become pregnant, or is nursing.
  4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
  5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
  6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
  7. Subject is in acute renal failure.
  8. Subject has an active systemic infection.
  9. Subject is participating in another research study involving an investigational device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.
  10. Subject has other comorbidities that - in the opinion of the investigator - preclude them from receiving study treatment and/or from completing the required study follow-up assessments.
  11. Subject presents with acute limb ischemia or acute thrombosis of the target limb.
  12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.

  13. Subject had a stroke within 3 months of index procedure.

    Angiographic exclusion criteria

  14. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g embolism).
  15. Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g. embolism).
  16. Target lesion is within a previously placed stent.

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MicroStent and Standard PTA
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Enhet: MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
Aktiv komparator: Standard PTA
Enhet: Standard PTA
Standard PTA balloon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patency of the target lesion
Tidsramme: up to 6 months after randomization
Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.
up to 6 months after randomization
Freedom from perioperative death
Tidsramme: up to 30 days after randomization
Freedom from perioperative death
up to 30 days after randomization
Freedom from major adverse limb event
Tidsramme: up to 6 months after randomization
Freedom from major adverse limb event
up to 6 months after randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Freedom from major amputation above the ankle
Tidsramme: up to 6 months after randomization
Freedom from major amputation (above the ankle)
up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
Tidsramme: up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
up to 6 months after randomization
Freedom from major adverse limb event
Tidsramme: From date of randomization until the date of death from any cause assessed up to 36 months
Freedom from major adverse limb event
From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure related adverse events
Tidsramme: From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study.
From date of randomization until the date of death from any cause assessed up to 36 months

Samarbeidspartnere og etterforskere

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

Sponsor

Micro Medical Solution, Inc.

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 (Faktiske)

19. juni 2019

Primær fullføring (Forventet)

1. juli 2023

Studiet fullført (Forventet)

1. juli 2026

Datoer for studieregistrering

Først innsendt

8. mars 2018

Først innsendt som oppfylte QC-kriteriene

19. mars 2018

Først lagt ut (Faktiske)

26. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. oktober 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. oktober 2022

Sist bekreftet

1. oktober 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MMS-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Perifer arteriell sykdom

Kliniske studier på MicroStent and Standard PTA

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