Peripheral Arterial DiseaseSAVERNCT02769273
Stellarex Vascular E-Registry
An observational study of Peripheral Arterial Disease, run by Spectranetics Corporation at 46 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Percutaneous Transluminal Angioplasty
- Type of treatment
- Medical device
- How many people
- 1,900 participants
- Where
- 46 sitesin 6 countries
- Study dates
- Jun 2016to Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
46 sites in 6 countries.
46 sites in 6 countries
Germany13 sites
Klinikum Arnsberg
Arnsberg
Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin
MediClin Herzzentrum Coswig
Coswig
Klinikum Doebeln GmbH
Döbeln
Cardioangiologisches Centrum Bethanien
Frankfurt
Krankenhäuser Landkreis Freudenstadt GmbH
Freudenstadt
Universitätsklinikum Halle
Halle
Asklepios Klinikum Harburg
Hamburg
Universitätsklinikum Jena
Jena
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe
Universitätsklinikum Leipzig
Leipzig
Saint Vincenz Hospital
Limburg
St. Franziskus-Hospital GmbH
Münster
France10 sites
Clinique Générale Annecy
Annecy
Clinique Rhone Durance
Avignon
Clinique Saint Augustin
Bordeaux
Clinique Tivoli
Bordeaux
Clinique Médipole De Savoie
Challes-les-Eaux
Grand Hôpital de l'Est Francilien - Site de Marne la Vallée
Jossigny
Groupe hospitalier Saint Joseph
Paris
Polyclinique de la Baie
Saint-Martin-des-Champs
Clinique Pasteur
Toulouse
Clinique Sarrus teinturiers Rive Gauche
Toulouse
Belgium9 sites
OLV Aalst
Aalst
Imelda
Bonheiden
Europe Hospital
Brussels
AZ Sint Blasius
Dendermonde
UZA Antwerpen
Edegem, Edegem, 2650
Universitair Ziekenhuis Gent
Ghent
Jessa Ziekenhuis Hasselt
Hasselt
AZ Groeninge
Kortrijk
H.Hart Tienen
Tienen
Italy6 sites
Âzienda Ospedaliera Per L'emergenza Cannizzaro
Catania
AZ Ospedaliera M. Mellini Chiari
Chiari
Clinica Montevergine
Mercogliano
Ospedale Civile Di Mirano
Mirano
Multimedica
Sesto San Giovanni
"Villa Berica" Gruppo Garofalo
Vicenza
United Kingdom5 sites
The Royal Bournemouth Hospital
Bournemouth
North Bristol NHS Trust
Bristol
Stoke Mandeville Hospital
Buckingham
"Saint George's Vascular Institute
London
Royal Free Hospital
London
Austria3 sites
Medical University Graz
Graz
Krankenhaus der Barmherzigen Schwesterrn Reid
Ried im Innkreis
Krankenhaus Göttlicher Heiland GmbH
Vienna
About this study
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
- Being tested
- Percutaneous Transluminal Angioplasty
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Transluminal AngioplastyDevice
Also called Stellarex™ OTW Drug-coated Angioplasty Balloon
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | RCC 2-3 Receives: Device: Percutaneous Transluminal Angioplasty | |
| Cohort 2 | RCC 4-6 (CLI) Receives: Device: Percutaneous Transluminal Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint Cohort 1 - RCC 2-3:
Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure.
Measured: 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.
Measured: 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.
Measured: 6 Months post procedure
Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)
Freedom from Composite MALE and POD through 30 days
Measured: 30days
Secondary outcomes (2)
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
Measured: 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
Measured: As specified in the description
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completion31 Oct 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769273
- Sponsor's protocol ID
- D029260
- Acronym
- SAVER
- Status last verified
- Aug 2025
- First submitted
- 10 May 2016
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 31567024
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellarex Vascular E-Registry
- ClinicalTrials.gov ID
- NCT02769273
- Acronym / sponsor ID
- SAVER / D029260
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Percutaneous Transluminal AngioplastyRCC 2-3 |
| Cohort 2 | – | Device: Percutaneous Transluminal AngioplastyRCC 4-6 (CLI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
- Patients confined to bed that are completely non ambulatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Transluminal AngioplastyAlso: Stellarex™ OTW Drug-coated Angioplasty Balloon | Device | Cohort 1, Cohort 2 |
Primary outcome
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.
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.
Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI)
Time frame: 6 Months post procedure
Freedom from CD-TLR at 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
2 secondary outcomes
Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3
Time frame: as specified in the description
Rate and Freedom-from-Cohort 2 - RCC 4-6
Time frame: As specified in the description
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 31567024Gray 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.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Spectranetics Corporation at 46 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Germany, France, Belgium, Italy, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint Cohort 1 - RCC 2-3: (time frame: 12 months post-procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.