[Essai de dispositif qui n'est pas approuvé ou effacé par la FDA américaine]
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).
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Noah Shields
- Numéro de téléphone: 321174 765-463-7537
- E-mail: noah.shields@cookmedical.com
Lieux d'étude
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California
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Long Beach, California, États-Unis, 90822
- Recrutement
- Long Beach Veterans Administration Hospital/SCIRE Research
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Recrutement
- Yale New Haven Hospital
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-
District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20007
- Recrutement
- Medstar Georgetown University Hopsital
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Florida
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Gainesville, Florida, États-Unis, 32605
- Recrutement
- The Cardiac and Vascular Institute
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Jacksonville, Florida, États-Unis, 32256
- Recrutement
- First Coast Cardiovascular Institute
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Miami, Florida, États-Unis, 33176
- Recrutement
- Baptist Cardiac and Vascular Institute
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Iowa
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Davenport, Iowa, États-Unis, 52801
- Recrutement
- Midwest Cardiovascular Research Foundation
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Michigan
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Bay City, Michigan, États-Unis, 48708
- Recrutement
- McLaren Bay Region Hospital
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Mississippi
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Tupelo, Mississippi, États-Unis, 33801
- Recrutement
- North Mississippi Medical Center
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Recrutement
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, États-Unis, 08103
- Recrutement
- Cooper University Hospital
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South Carolina
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Greenville, South Carolina, États-Unis, 26905
- Recrutement
- Prisma Health Memorial
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Texas
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Dallas, Texas, États-Unis, 75235
- Recrutement
- University of Texas Southwestern
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Houston, Texas, États-Unis, 77030
- Recrutement
- Houston Methodist Hospital
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Humble, Texas, États-Unis, 77338
- Recrutement
- Vital Heart and Vein
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary safety endpoint
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Eric Secemsky, MD, Beth Israel Deaconess Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24-04
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
Qualified scientific researchers
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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