Stellarex Vascular E-Registry

NCT02769273 | Completed

• 1 other identifier: D029260
• Study Type: observational
• Target: 1,900
• Locations: 6 countries
• Sites: 46

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3

  as specified in the description

• Rate and Freedom-from-Cohort 2 - RCC 4-6

  As specified in the description

Study Arms (2)

Cohort 1

RCC 2-3

Device: Percutaneous Transluminal Angioplasty

Cohort 2

RCC 4-6 (CLI)

Device: Percutaneous Transluminal Angioplasty

Interventions

Percutaneous Transluminal Angioplasty DEVICE

Also known as: Stellarex™ OTW Drug-coated Angioplasty Balloon

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (46)

Medical University Graz

Graz, Austria

Location

Krankenhaus der Barmherzigen Schwesterrn Reid

Ried im Innkreis, Austria

Location

Krankenhaus Göttlicher Heiland GmbH

Vienna, Austria

Location

UZA Antwerpen

Edegem, Edegem, 2650, Belgium

Location

OLV Aalst

Aalst, Belgium

Location

Imelda

Bonheiden, Belgium

Location

Europe Hospital

Brussels, Belgium

Location

AZ Sint Blasius

Dendermonde, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

H.Hart Tienen

Tienen, Belgium

Location

Clinique Générale Annecy

Annecy, France

Location

Clinique Rhone Durance

Avignon, France

Location

Clinique Saint Augustin

Bordeaux, France

Location

Clinique Tivoli

Bordeaux, France

Location

Clinique Médipole De Savoie

Challes-les-Eaux, France

Location

Grand Hôpital de l'Est Francilien - Site de Marne la Vallée

Jossigny, France

Location

Groupe hospitalier Saint Joseph

Paris, France

Location

Polyclinique de la Baie

Saint-Martin-des-Champs, France

Location

Clinique Pasteur

Toulouse, France

Location

Clinique Sarrus teinturiers Rive Gauche

Toulouse, France

Location

Klinikum Arnsberg

Arnsberg, Germany

Location

Ev. Krankenhaus Königin Elisabeth Herzberge

Berlin, Germany

Location

MediClin Herzzentrum Coswig

Coswig, Germany

Location

Klinikum Doebeln GmbH

Döbeln, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Krankenhäuser Landkreis Freudenstadt GmbH

Freudenstadt, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Asklepios Klinikum Harburg

Hamburg, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Saint Vincenz Hospital

Limburg, Germany

Location

St. Franziskus-Hospital GmbH

Münster, Germany

Location

Âzienda Ospedaliera Per L'emergenza Cannizzaro

Catania, Italy

Location

AZ Ospedaliera M. Mellini Chiari

Chiari, Italy

Location

Clinica Montevergine

Mercogliano, Italy

Location

Ospedale Civile Di Mirano

Mirano, Italy

Location

Multimedica

Sesto San Giovanni, Italy

Location

"Villa Berica" Gruppo Garofalo

Vicenza, Italy

Location

The Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

Stoke Mandeville Hospital

Buckingham, United Kingdom

Location

"Saint George's Vascular Institute

London, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31567024 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: October 31, 2021
• Study Completion: December 1, 2021
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); FR (10); BE (9); IT (6); GB (5); DE (13)