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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

177

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MicroStent and Standard PTA
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Enhed: MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
Aktiv komparator: Standard PTA
Enhed: Standard PTA
Standard PTA balloon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Micro Medical Solution, Inc.

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 (Faktiske)

19. juni 2019

Primær færdiggørelse (Forventet)

1. juli 2023

Studieafslutning (Forventet)

1. juli 2026

Datoer for studieregistrering

Først indsendt

8. marts 2018

Først indsendt, der opfyldte QC-kriterier

19. marts 2018

Først opslået (Faktiske)

26. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MMS-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Perifer arteriel sygdom

Kliniske forsøg med MicroStent and Standard PTA

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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