Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1900 participants
OBSERVATIONAL
2016-06-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cohort 1
RCC 2-3
Percutaneous Transluminal Angioplasty
Cohort 2
RCC 4-6 (CLI)
Percutaneous Transluminal Angioplasty
Interventions
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Percutaneous Transluminal Angioplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines
* Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the superficial femoral, popliteal and/or infra-popliteal arteries\*
* Rutherford Clinical Category (RCC) 2-6 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines
* Age ≥18 years old
* Life expectancy \> 1 year
* Is able and willing to provide written informed consent prior to enrollment in the study (as applicable)
* Is able and willing to come on site or to be contacted by phone for the follow-up
Exclusion Criteria
* Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
* Patients with severe disease of foot circulation defined as:
* "desert foot" (absence of any angiographically visible arterial network below the ankle)
* Or lack of a patent (\<50%DS) and hemodynamically relevant wound related arterial pathway in the foot
* Patients confined to bed that are completely non ambulatory
18 Years
ALL
No
Sponsors
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Spectranetics Corporation
INDUSTRY
Responsible Party
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Locations
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Medical University Graz
Graz, , Austria
Krankenhaus der Barmherzigen Schwesterrn Reid
Ried im Innkreis, , Austria
Krankenhaus Göttlicher Heiland GmbH
Vienna, , Austria
UZA Antwerpen
Edegem, Edegem, Belgium
OLV Aalst
Aalst, , Belgium
Imelda
Bonheiden, , Belgium
Europe Hospital
Brussels, , Belgium
AZ Sint Blasius
Dendermonde, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Jessa Ziekenhuis Hasselt
Hasselt, , Belgium
AZ Groeninge
Kortrijk, , Belgium
H.Hart Tienen
Tienen, , Belgium
Clinique Générale Annecy
Annecy, , France
Clinique Rhone Durance
Avignon, , France
Clinique Saint Augustin
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Clinique Médipole De Savoie
Challes-les-Eaux, , France
Grand Hôpital de l'Est Francilien - Site de Marne la Vallée
Jossigny, , France
Groupe hospitalier Saint Joseph
Paris, , France
Polyclinique de la Baie
Saint-Martin-des-Champs, , France
Clinique Pasteur
Toulouse, , France
Clinique Sarrus teinturiers Rive Gauche
Toulouse, , France
Klinikum Arnsberg
Arnsberg, , Germany
Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin, , Germany
MediClin Herzzentrum Coswig
Coswig, , Germany
Klinikum Doebeln GmbH
Döbeln, , Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Krankenhäuser Landkreis Freudenstadt GmbH
Freudenstadt, , Germany
Universitätsklinikum Halle
Halle, , Germany
Asklepios Klinikum Harburg
Hamburg, , Germany
Universitätsklinikum Jena
Jena, , Germany
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Saint Vincenz Hospital
Limburg, , Germany
St. Franziskus-Hospital GmbH
Münster, , Germany
Âzienda Ospedaliera Per L'emergenza Cannizzaro
Catania, , Italy
AZ Ospedaliera M. Mellini Chiari
Chiari, , Italy
Clinica Montevergine
Mercogliano, , Italy
Ospedale Civile Di Mirano
Mirano, , Italy
Multimedica
Sesto San Giovanni, , Italy
"Villa Berica" Gruppo Garofalo
Vicenza, , Italy
The Royal Bournemouth Hospital
Bournemouth, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Stoke Mandeville Hospital
Buckingham, , United Kingdom
"Saint George's Vascular Institute
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Countries
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References
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Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.
Other Identifiers
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D029260
Identifier Type: -
Identifier Source: org_study_id
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