Stellarex Vascular E-Registry (SAVER)

January 25, 2022 updated by: Spectranetics Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medical University Graz
      • Ried im Innkreis, Austria
        • Krankenhaus der Barmherzigen Schwesterrn Reid
      • Vienna, Austria
        • Krankenhaus Göttlicher Heiland GmbH
  • Belgium
      • Aalst, Belgium
        • OLV Aalst
      • Bonheiden, Belgium
        • Imelda
      • Brussels, Belgium
        • Europe Hospital
      • Dendermond, Belgium
        • AZ Sint Blasius
      • Edegem, Belgium, 2650
        • UZA Antwerpen
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
      • Hasselt, Belgium
        • Jessa Ziekenhuis Hasselt
      • Kortrijk, Belgium
        • AZ Groeninge
      • Tienen, Belgium
        • H.Hart Tienen
  • France
      • Annecy, France
        • Clinique Générale Annecy
      • Avignon, France
        • Clinique Rhône Durance
      • Bordeaux, France
        • Clinique Saint Augustin
      • Bordeaux, France
        • Clinique Tivoli
      • Challes Les Eaux, France
        • Clinique Médipole De Savoie
      • Jossigny, France
        • Grand Hôpital de l'Est Francilien - Site de Marne la Vallée
      • Paris, France
        • Groupe Hospitalier Saint Joseph
      • Saint Martin des Champs, France
        • Polyclinique de la Baie
      • Toulouse, France
        • Clinique Sarrus teinturiers Rive Gauche
      • Toulouse Cedex 3, France
        • Clinique Pasteur
  • Germany
      • Arnsberg, Germany
        • Klinikum Arnsberg
      • Berlin, Germany
        • Ev. Krankenhaus Königin Elisabeth Herzberge
      • Coswig / Sachsen Anhalt, Germany
        • MediClin Herzzentrum Coswig
      • Doebeln, Germany
        • Klinikum Doebeln GmbH
      • Frankfurt, Germany
        • Cardioangiologisches Centrum Bethanien
      • Freundenstadt, Germany
        • Krankenhäuser Landkreis Freudenstadt GmbH
      • Halle a.d.Saale, Germany
        • Universitätsklinikum Halle
      • Hamburg, Germany
        • Asklepios Klinikum Harburg
      • Jena, Germany
        • Universitätsklinikum Jena
      • Karlsruhe, Germany
        • Städtisches Klinikum Karlsruhe gGmbH
      • Leipzig, Germany
        • Universitatsklinikum Leipzig
      • Limburg, Germany
        • Saint Vincenz Hospital
      • Munster, Germany
        • St. Franziskus-Hospital GmbH
  • Italy
      • Catania, Italy
        • Azienda Ospedaliera per l'emergenza Cannizzaro
      • Chiari, Italy
        • AZ Ospedaliera M. Mellini Chiari
      • Mercogliano AV, Italy
        • Clinica Montevergine
      • Mirano, Italy
        • Ospedale Civile di Mirano
      • Sento San Giovanni (Milan), Italy
        • Multimedica
      • Vicenza, Italy
        • "Villa Berica" Gruppo Garofalo
  • United Kingdom
      • Bournemouth, United Kingdom
        • The Royal Bournemouth Hospital
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Buckinghamshire, United Kingdom
        • Stoke Mandeville Hospital
      • London, United Kingdom
        • Royal Free Hospital
      • London, United Kingdom
        • "Saint George's Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint
Time Frame: 12 months post-procedure
Freedom from Clinically Driven Target Lesion Revascularization
12 months post-procedure
Primary Safety Endpoint
Time Frame: 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
12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectranetics Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D029260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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