Stellarex Vascular E-Registry (SAVER)

August 13, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
      • Dendermonde, 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, Germany
        • MediClin Herzzentrum Coswig
      • Döbeln, Germany
        • Klinikum Doebeln GmbH
      • Frankfurt, Germany
        • Cardioangiologisches Centrum Bethanien
      • Freudenstadt, Germany
        • Krankenhäuser Landkreis Freudenstadt GmbH
      • Halle, Germany
        • Universitätsklinikum Halle
      • Hamburg, Germany
        • Asklepios Klinikum Harburg
      • Jena, Germany
        • Universitatsklinikum 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, Italy
        • Clinica Montevergine
      • Mirano, Italy
        • Ospedale Civile Di Mirano
      • Sesto San Giovanni, Italy
        • Multimedica
      • Vicenza, Italy
        • "Villa Berica" Gruppo Garofalo
  • United Kingdom
      • Bournemouth, United Kingdom
        • The Royal Bournemouth Hospital
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Buckingham, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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
  • 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:

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 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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
RCC 2-3
Device: Percutaneous Transluminal Angioplasty
Other Names:
  • Stellarex™ OTW Drug-coated Angioplasty Balloon
Cohort 2
RCC 4-6 (CLI)
Device: Percutaneous Transluminal Angioplasty
Other Names:
  • Stellarex™ OTW Drug-coated Angioplasty Balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint Cohort 1 - RCC 2-3:
Time Frame: 12 months post-procedure
Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure.
12 months post-procedure
Primary Safety Endpoint-Cohort 1 - RCC 2-3
Time Frame: 30 days post-procedure - 12Month post procedure
Freedom from device and procedure- related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure.
30 days post-procedure - 12Month post procedure
Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI)
Time Frame: 6 Months post procedure
Freedom from CD-TLR at 6 months post-procedure.
6 Months post procedure
Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)
Time Frame: 30days
Freedom from Composite MALE and POD through 30 days
30days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3
Time Frame: as specified in the description
  • All-cause mortality at 12, 24 and 36 months post- procedure
  • Cardiovascular death at 12, 24, 36 months post- procedure
  • Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure
  • Device or procedure related death at 30 days
  • Major target limb amputation at 12, 24, 36 months post-procedure
  • CD-TLR through 12 (rate only), 24 and 36 months
  • Clinically Driven- Target Vessel Revascularization (CD- TVR) through 12, 24 and 36 months
as specified in the description
Rate and Freedom-from-Cohort 2 - RCC 4-6
Time Frame: As specified in the description

All-cause mortality at 6, 12, 24 and 36 months post- procedure

  • Cardiovascular death at 6, 12, 24, 36 months post- procedure
  • Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure
  • Device or procedure related death at 30 days o Major target limb amputation at 6, 12, 24, 36 months post-procedure
  • CD-TLR through 6 (rate only), 12, 24 and 36 months o Clinically Driven- Target Vessel Revascularization (CD- TVR) through 6, 12, 24 and 36 months
  • Wound healing rate through 6, 12, 24, and 36 months post-procedure
  • Minor amputation through 6, 12, 24 and 36 months
  • Amputation-free survival through 6, 12, 24 and 36 months
As specified in the description

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D029260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

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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