Stellarex Vascular E-Registry (SAVER)

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: Peripheral Arterial Disease
• Intervention / Treatment: Device: Percutaneous Transluminal Angioplasty

• Study Type: Observational
• Enrollment (Actual): 1900

Contacts and Locations

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
    • Universitatsklinikum Halle
  • Hamburg, Germany
    • Asklepios Klinikum Harburg
  • Jena, Germany
    • Universitätsklinikum Jena
  • Karlsruhe, Germany
    • Städtisches Klinikum Karlsruhe gGmbH
  • Leipzig, Germany
    • Universitätsklinikum 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint Cohort 1 - RCC 2-3:	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	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)	Freedom from CD-TLR at 6 months post-procedure.	6 Months post procedure
Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)	Freedom from Composite MALE and POD through 30 days	30days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3	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	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

• Sponsor: Spectranetics Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

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 (Estimated): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID 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