Brief description of trial (Data source: 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.
Health conditions investigated(Data source: 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
(Data source: WHO)
PAD;Vascular Calcification
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: 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
(Data source: WHO)
Device: Peripheral Orbital Atherectomy System;Device: 014 Drug Coated Balloon
Criteria for participation in trial
(Data source: 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
Exclusion criteria
(Data source: 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
(Data source: 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
-
Further information on trial
Recruitment status
Completed
Academic title
(Data source: WHO)
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: 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
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Luzern
Countries
(Data source: WHO)
Austria, Germany, Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Salem Arefe
+16512592016
sarefe@csi360.com
Contact for general information
(Data source: 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
Contact for scientific information
(Data source: 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
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
06.04.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00081
Secondary ID (Data source: WHO)
CLN-0007-P
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