[Prøving av enhet som ikke er godkjent eller ryddet av U.S. FDA]
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon [DCB]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Noah Shields
- Telefonnummer: 321174 765-463-7537
- E-post: noah.shields@cookmedical.com
Studiesteder
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California
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Long Beach, California, Forente stater, 90822
- Rekruttering
- Long Beach Veterans Administration Hospital/SCIRE Research
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Yale New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- Rekruttering
- Medstar Georgetown University Hopsital
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Florida
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Gainesville, Florida, Forente stater, 32605
- Rekruttering
- The Cardiac and Vascular Institute
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Jacksonville, Florida, Forente stater, 32256
- Rekruttering
- First Coast Cardiovascular Institute
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Miami, Florida, Forente stater, 33176
- Rekruttering
- Baptist Cardiac and Vascular Institute
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Iowa
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Davenport, Iowa, Forente stater, 52801
- Rekruttering
- Midwest Cardiovascular Research Foundation
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Michigan
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Bay City, Michigan, Forente stater, 48708
- Rekruttering
- McLaren Bay Region Hospital
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Mississippi
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Tupelo, Mississippi, Forente stater, 33801
- Rekruttering
- North Mississippi Medical Center
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Rekruttering
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Forente stater, 08103
- Rekruttering
- Cooper University Hospital
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South Carolina
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Greenville, South Carolina, Forente stater, 26905
- Rekruttering
- Prisma Health Memorial
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Texas
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Dallas, Texas, Forente stater, 75235
- Rekruttering
- University of Texas Southwestern
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Hospital
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Humble, Texas, Forente stater, 77338
- Rekruttering
- Vital Heart and Vein
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Documented PAD with Rutherford classification 2 - 4; and
- De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.
Exclusion Criteria:
General Exclusion Criteria
- Less than 18 years old;
- Inability or refusal to give informed consent by the patient or legally authorized representative;
- Life expectancy ≤ 12 months, per investigator assessment;
- Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
- Unable or unwilling to comply with the follow-up schedule; or
- Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Evero DCB
Treatment with Evero drug-coated balloon to apply local treatment with everolimus |
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries |
|
Aktiv komparator: Paclitaxel-coated DCB
Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel |
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary safety endpoint
Tidsramme: 30 days (death); 12 months (amputation and CD-TLR)
|
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR) |
30 days (death); 12 months (amputation and CD-TLR)
|
|
Primary effectiveness endpoint
Tidsramme: 12 months
|
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR. |
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Eric Secemsky, MD, Beth Israel Deaconess Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-04
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.
html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
IPD-delingstidsramme
Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication.
Tilgangskriterier for IPD-deling
Qualified scientific researchers
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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