[Försök med enhet som inte är godkänd eller rensad av den amerikanska 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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Noah Shields
- Telefonnummer: 321174 765-463-7537
- E-post: noah.shields@cookmedical.com
Studieorter
-
-
California
-
Long Beach, California, Förenta staterna, 90822
- Rekrytering
- Long Beach Veterans Administration Hospital/SCIRE Research
-
-
Connecticut
-
New Haven, Connecticut, Förenta staterna, 06510
- Rekrytering
- Yale New Haven Hospital
-
-
District of Columbia
-
Washington D.C., District of Columbia, Förenta staterna, 20007
- Rekrytering
- Medstar Georgetown University Hopsital
-
-
Florida
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Gainesville, Florida, Förenta staterna, 32605
- Rekrytering
- The Cardiac and Vascular Institute
-
Jacksonville, Florida, Förenta staterna, 32256
- Rekrytering
- First Coast Cardiovascular Institute
-
Miami, Florida, Förenta staterna, 33176
- Rekrytering
- Baptist Cardiac and Vascular Institute
-
-
Iowa
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Davenport, Iowa, Förenta staterna, 52801
- Rekrytering
- Midwest Cardiovascular Research Foundation
-
-
Michigan
-
Bay City, Michigan, Förenta staterna, 48708
- Rekrytering
- McLaren Bay Region Hospital
-
-
Mississippi
-
Tupelo, Mississippi, Förenta staterna, 33801
- Rekrytering
- North Mississippi Medical Center
-
-
New Hampshire
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Rekrytering
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
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Camden, New Jersey, Förenta staterna, 08103
- Rekrytering
- Cooper University Hospital
-
-
South Carolina
-
Greenville, South Carolina, Förenta staterna, 26905
- Rekrytering
- Prisma Health Memorial
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75235
- Rekrytering
- University of Texas Southwestern
-
Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Houston Methodist Hospital
-
Humble, Texas, Förenta staterna, 77338
- Rekrytering
- Vital Heart and Vein
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary safety endpoint
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Eric Secemsky, MD, Beth Israel Deaconess Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 24-04
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
Qualified scientific researchers
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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