Clinical trial NCT02769273: Stellarex Vascular E-Registry
Official title: Stellarex Vascular E-Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic stenosis of the superficial femoral artery and/or popliteal artery intended to be treated with a Percutaneous Transluminal Angioplasty using the Stellarex OTW Drug -Coated Balloon

Brief summary: Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.


Eligibility criteria: Inclusion Criteria:

* Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries
* Rutherford Clinical Category (RCC) 2-3 or 4 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:

* Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion
* Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
* Patients that in the judgment of the investigator would need treatment below the knee before and/or during the index procedure.

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: 12 months post-procedure
measure: Primary Safety Endpoint
timeFrame: 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Ried im Innkreis
country: Austria
facility: Krankenhaus der Barmherzigen Schwesterrn Reid
city: Vienna
country: Austria
facility: Krankenhaus Göttlicher Heiland GmbH
city: Aalst
country: Belgium
facility: OLV Aalst
city: Bonheiden
country: Belgium
facility: Imelda
city: Brussels
country: Belgium
facility: Europe Hospital
city: Dendermond
country: Belgium
facility: AZ Sint Blasius
city: Edegem
country: Belgium
facility: UZA Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hasselt
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Tienen
country: Belgium
facility: H.Hart Tienen
city: Annecy
country: France
facility: Clinique Générale Annecy
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Challes Les Eaux
country: France
facility: Clinique Médipole De Savoie
city: Jossigny
country: France
facility: Grand Hôpital de l'Est Francilien - Site de Marne la Vallée
city: Paris
country: France
facility: Groupe hospitalier Saint Joseph
city: Saint Martin des Champs
country: France
facility: Polyclinique de la Baie
city: Toulouse Cedex 3
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Clinique Sarrus teinturiers Rive Gauche
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg
city: Berlin
country: Germany
facility: Ev. Krankenhaus Königin Elisabeth Herzberge
city: Coswig / Sachsen Anhalt
country: Germany
facility: MediClin Herzzentrum Coswig
city: Doebeln
country: Germany
facility: Klinikum Doebeln GmbH
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Freundenstadt
country: Germany
facility: Krankenhäuser Landkreis Freudenstadt GmbH
city: Halle a.d.Saale
country: Germany
facility: Universitätsklinikum Halle
city: Hamburg
country: Germany
facility: Asklepios Klinikum Harburg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Limburg
country: Germany
facility: Saint Vincenz Hospital
city: Munster
country: Germany
facility: St. Franziskus-Hospital GmbH
city: Catania
country: Italy
facility: Âzienda Ospedaliera Per L'emergenza Cannizzaro
city: Chiari
country: Italy
facility: AZ Ospedaliera M. Mellini Chiari
city: Mercogliano AV
country: Italy
facility: Clinica Montevergine
city: Mirano
country: Italy
facility: Ospedale Civile Di Mirano
city: Sento San Giovanni (Milan)
country: Italy
facility: Multimedica
city: Vicenza
country: Italy
facility: "Villa Berica" Gruppo Garofalo
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Buckinghamshire
country: United Kingdom
facility: Stoke Mandeville Hospital
city: London
country: United Kingdom
facility: "Saint George's Vascular Institute
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
References:
citation: 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.