Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Diese prospektive, randomisierte, multizentrische post-Marketing Pilotstudie umfasst 50 Patienten mit kalzifizierten Läsionen der distalen Arteria poplitea, der Arteria tibialis anterior, der Arteria tibialis posterior, des Truncus tibiofibularis oder der Arteria peronea mit einer Stenose gemäss Angiographie von ≥ 70 % Durchmesser.
Malattie studiate(Fonte di dati: BASEC)
Der Zweck dieser Studie ist die prospektive Beurteilung der akuten und langfristigen klinischen Ergebnisse der orbitalen Atherektomie mit adjunktiver Angioplastie mit einem medikamentenbeschichteten Ballon gegenüber einer Angioplastie mit einem medikamentenbeschichteten Ballon allein zur Behandlung der peripheren arteriellen Verschlusskrankheit bei Läsionen unterhalb des Knies.
Health conditions
(Fonte di dati: WHO)
PAD;Vascular Calcification
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Das System besteht aus dem in der Hand zu haltenden Orbitalatherektomie-Katheter (Katheter), der CSI Kochsalzlösung-Infusionspumpe (Pumpe), dem CSI VIPERWIRE ADVANCE Atherektomie-Führungsdraht (Führungsdraht) sowie dem CSI VIPERSLIDE Gleitmittel (Gleitmittel). Das System trägt mithilfe einer rotierenden, diamantbeschichteten Krone in den peripheren Arterien okklusives Material ab bzw. Eftfernt es, um die Durchgängigkeit des Lumens wiederherzustellen.
Die Patienten werden randomisiert im Verhältnis 1:1 (Wie bei einem Münzwurf) der orbitalen Atherektomie mit adjunktiver Angioplastie mit einem medikamentenbeschichteten Ballon gegenüber einer Angioplastie mit einem medikamentenbeschichteten Ballon allein zugewiesen.
Interventions
(Fonte di dati: WHO)
Device: Peripheral Orbital Atherectomy System;Device: 014 Drug Coated Balloon
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
- Klinische Rutherford-Kategorie 3–5
- Läsionen (ausgenommen In-Stent-Restenosen [ISR]) der distalen Arteria POP
(POP-Segment unterhalb des anatomischen Kniegelenks), AT, PT, TPT und PR mit ≥ 70 % DS gemäß Angiografie
- Vorliegen einer deutlich sichtbaren Kalzifikation in zwei Ansichten (beide
Seiten des Gefäßes an derselben Stelle) gemäß angiografischer Beurteilung mittels Computertomografie (CT) erstellte angiografische Aufnahmen
können ersatzweise zur Bestätigung der Kalziumverteilung herangezogen
werden, wenn als Versorgungsstandard verfügbar
Criteri di esclusione
(Fonte di dati: BASEC)
- Kontraindikation für beide Geräte, gemäss Gebrauchsanweisung
- Geplante Amputation (auch Minoramputation) der Index-Extremität oder vorherige Majoramputation der kontralateralen Extremität
- Kreatinin > 2,5 mg/dl, sofern nicht auf Dialyse
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Subject's age = 18 years
- Rutherford Clinical Category 3 - 5
- Lesions [except in-stent restenosis (ISR)] of the distal popliteal (POP segment below
the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk,
and peroneal arteries with = 70 % diameter stenosis (DS) by angiography
- Presence of clearly visible calcification in two views (both sides of vessel at the
same location) evaluated angiographically- [Computerized tomography (CT) angio images
may substitute to confirm distribution of calcium, if available as standard of care]
- Length of calcium = 25 % of total lesion length or = 2 cm total length
- Target lesion length up to 20 cm
Exclusion Criteria:
- Subject or subject's legal representative is not willing to sign an Ethics Committee
approved informed consent form or comply with the study protocol requirements
- Contraindicated by either device, per Instructions For Use
- Presence of inflow lesion (= 50 % DS) or inflow not successfully treated (= 50% DS
and/or unresolved significant angiographic complication)
- Compromised outflow distal to the target lesion (= 70 % DS) or presence of lesion(s)
or occlusion(s) located from 5 cm above the ankle to below the ankle joint space
- Subject has more than 2 target vessels requiring treatment
- The guide wire cannot be passed across the target lesion(s) and/or guide wire position
distal to target lesion(s) outside vessel lumen
- Presence of significant (= 70 % DS) lesion(s) or occlusion(s) not meeting the study
criteria which were not successfully treated during the index procedure (= 50 % DS
and/or significant angiographic complication)
- Subject has planned amputation (including minor) of the index limb or previous major
amputation of the contralateral limb
- Creatinine > 2.5 mg/dL, unless on dialysis
- Subject has any significant medical condition which, in the Investigator's opinion,
may interfere with the subject's optimal participation in the study
- Subject is participating in an investigational drug or device study that has the
potential to clinically interfere with the study outcome measures
- Subject is pregnant or planning to become pregnant within the study period
- Subject has an unresolved severe systemic infection
- Subject has an anticipated life span of less than one year
- Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds
- Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy
- Pre-dilatation of the target lesion prior to randomization and OA treatment
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
N/A
Punti finali primari
(Fonte di dati: WHO)
Device Success;Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure;Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure;Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure;Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure;Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Luzern
Paesi di esecuzione
(Fonte di dati: WHO)
Austria, Germany, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Salem Arefe
+16512592016
sarefe@csi360.com
Contatto per informazioni generali
(Fonte di dati: WHO)
Professor Marianne Brodmann, Dr.;Professor Gunnar Tepe, Dr.;Professor Thomas Zeller, Dr.
Medical University of Graz, Austria;Klinikum Rosenheim Germany;Herz-Zentrum Bad Krozingen Germany
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Professor Marianne Brodmann, Dr.;Professor Gunnar Tepe, Dr.;Professor Thomas Zeller, Dr.
Medical University of Graz, Austria;Klinikum Rosenheim Germany;Herz-Zentrum Bad Krozingen Germany
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Data di autorizzazione da parte della commissione d’etica
06.04.2016
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2016-00081
Secondary ID (Fonte di dati: WHO)
CLN-0007-P
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