Stellarex Vascular E-Registry

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT02769273
• Lead Sponsor: Spectranetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Study Start: 2016-06
• Primary Completion: 2021-10-31
• Study Completion: 2021-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	12 months post-procedure	Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and Clinically Driven Target Lesion Revascularization through 12 months post-procedure
Primary Efficacy Endpoint	12 months post-procedure	Freedom from Clinically Driven Target Lesion Revascularization

Trial Locations

Locations (46)

Ospedale Civile Di Mirano; 🇮🇹 Mirano, Italy

The Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Klinikum Doebeln GmbH; 🇩🇪 Doebeln, Germany

Krankenhaus der Barmherzigen Schwesterrn Reid; 🇦🇹 Ried im Innkreis, Austria

Medical University Graz; 🇦🇹 Graz, Austria

Imelda; 🇧🇪 Bonheiden, Belgium

Krankenhaus Göttlicher Heiland GmbH; 🇦🇹 Vienna, Austria

AZ Sint Blasius; 🇧🇪 Dendermond, Belgium

OLV Aalst; 🇧🇪 Aalst, Belgium

Europe Hospital; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

UZA Antwerpen; 🇧🇪 Edegem, Belgium

H.Hart Tienen; 🇧🇪 Tienen, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Jessa Ziekenhuis Hasselt; 🇧🇪 Hasselt, Belgium

Clinique Générale Annecy; 🇫🇷 Annecy, France

MediClin Herzzentrum Coswig; 🇩🇪 Coswig / Sachsen Anhalt, Germany

Grand Hôpital de l'Est Francilien - Site de Marne la Vallée; 🇫🇷 Jossigny, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Groupe hospitalier Saint Joseph; 🇫🇷 Paris, France

Clinique Rhone Durance; 🇫🇷 Avignon, France

Clinique Saint Augustin; 🇫🇷 Bordeaux, France

Clinique Médipole De Savoie; 🇫🇷 Challes Les Eaux, France

Polyclinique de la Baie; 🇫🇷 Saint Martin des Champs, France

Clinique Pasteur; 🇫🇷 Toulouse Cedex 3, France

Ev. Krankenhaus Königin Elisabeth Herzberge; 🇩🇪 Berlin, Germany

Clinique Sarrus teinturiers Rive Gauche; 🇫🇷 Toulouse, France

Klinikum Arnsberg; 🇩🇪 Arnsberg, Germany

Krankenhäuser Landkreis Freudenstadt GmbH; 🇩🇪 Freundenstadt, Germany

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Halle; 🇩🇪 Halle a.d.Saale, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Asklepios Klinikum Harburg; 🇩🇪 Hamburg, Germany

Städtisches Klinikum Karlsruhe gGmbH; 🇩🇪 Karlsruhe, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Saint Vincenz Hospital; 🇩🇪 Limburg, Germany

St. Franziskus-Hospital GmbH; 🇩🇪 Munster, Germany

Âzienda Ospedaliera Per L'emergenza Cannizzaro; 🇮🇹 Catania, Italy

AZ Ospedaliera M. Mellini Chiari; 🇮🇹 Chiari, Italy

Clinica Montevergine; 🇮🇹 Mercogliano AV, Italy

Multimedica; 🇮🇹 Sento San Giovanni (Milan), Italy

"Villa Berica" Gruppo Garofalo; 🇮🇹 Vicenza, Italy

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Stoke Mandeville Hospital; 🇬🇧 Buckinghamshire, United Kingdom

"Saint George's Vascular Institute; 🇬🇧 London, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom