Critical Limb IschemiaApolloNCT02539940
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
An observational study of Critical Limb Ischemia and Peripheral Artery Disease, run by Jena University Hospital at 10 sites in Germany.
Trial summary
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Artery Disease
- What is being tested?
- Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 10 sitesGermany
- Study dates
- Sep 2015to Oct 2018
- 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: The study population comprises patients in Germany who undergo treatment with the ELUTAX SV-DEB that is applied for treatment of peripheral arterial disease (PAD) in below-the-knee vessels.
Who may be able to join
- Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB
- Age ≥ 18 years
- Signed informed consent
- documented Critical Limb Ischemia (CLI) in the target limb prior to the study
- Rutherford Category 4, 5 or 6
- ≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion
Show all 9Show fewer
- Patent inflow artery
- Target vessel(s) diameter between 2 and 4 mm
- Target vessel(s) reconstitute(s) at or above the ankle
Who cannot join
- Life expectancy below 50% within the next 12 months (as judged by the investigator)
- Planned major index limb amputation
- Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis)
- Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed)
- Patient unwilling or unlikely to comply with follow-up schedule
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, 046600
Oberlausitz-Kliniken Bautzen
Bautzen, Saxony, 02625
DRK Kliniken Berlin Köpenick
Berlin, Brandenburg
Städtisches Krankenhaus Dresden-Friedrichstadt
Dresden, Saxony, 01067
SRH-Waldklinikum
Gera, Thuringia, 07548
University Hospital Jena, Radiology
Jena, Thuringia, 07747
Saale-Unstrut Klinikum Naumburg
Naumburg, Thuringia, 06618
MEDINOS Kliniken Sonneberg
Sonneberg, Thuringia, 96515
Kreiskrankenhaus Torgau "J. Kentmann" gGmbH
Torgau, 04860
Heinrich-Braun-Krankenhaus
Zwickau, Saxony, 08060
About this study
Official title: A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels
Read the detailed description
The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Being tested
- Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV
- Keywords
- Below-the-knee
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SVDevice
Angioplasty for revascularization in below-the-knee arteries
| Study group | Role | What they receive |
|---|---|---|
| Patients with critical limb ischemia | Patients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon). Receives: Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Rutherford Classification
Change of Rutherford stage to baseline at Follow-up visits
Measured: after 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionOct 2018
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 Critical Limb IschemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zentrum für Klinische Studien Jena, Aachen Resonance GmbH
- Responsible party
- Principal investigator, Ulf Teichgräber, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539940
- Sponsor's protocol ID
- 4448-06/15
- Acronym
- Apollo
- Status last verified
- Mar 2020
- First submitted
- 17 Aug 2015
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Teichgraber U, Lehmann T, Thieme M, Wahl KU, Stelzner C, Bormann A, Gotz L, Kroessner T, Boden H, Maiwald L, Aschenbach R. Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1380-1390. doi: 10.1007/s00270-019-02279-6. Epub 2019 Jul 8.
PubMed 31286197
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
- ClinicalTrials.gov ID
- NCT02539940
- Acronym / sponsor ID
- Apollo / 4448-06/15
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- Below-the-knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Zentrum für Klinische Studien Jena, Aachen Resonance GmbH
- Study start
- Sep 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 3 Sep 2015 (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.
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels
Detailed description
The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with critical limb ischemia | – | Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SVPatients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises patients in Germany who undergo treatment with the ELUTAX SV-DEB that is applied for treatment of peripheral arterial disease (PAD) in below-the-knee vessels.
Key inclusion criteria (9 listed)
- Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB
- Age ≥ 18 years
- Signed informed consent
- documented Critical Limb Ischemia (CLI) in the target limb prior to the study
- Rutherford Category 4, 5 or 6
Key exclusion criteria (5 listed)
- Life expectancy below 50% within the next 12 months (as judged by the investigator)
- Planned major index limb amputation
- Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis)
- Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed)
- Patient unwilling or unlikely to comply with follow-up schedule
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 |
|---|---|---|
| Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SVAngioplasty for revascularization in below-the-knee arteries | Device | Patients with critical limb ischemia |
Primary outcome
Change of Rutherford Classification
Time frame: after 6 and 12 month
Change of Rutherford stage to baseline at Follow-up visits
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 10 Mar 2020.
- Derived from this study: PubMed 31286197Teichgraber U, Lehmann T, Thieme M, Wahl KU, Stelzner C, Bormann A, Gotz L, Kroessner T, Boden H, Maiwald L, Aschenbach R. Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1380-1390. doi: 10.1007/s00270-019-02279-6. Epub 2019 Jul 8.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia and Peripheral Artery Disease, run by Jena University Hospital at 10 sites in Germany.
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 9 inclusion and 5 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
Change of Rutherford Classification (time frame: after 6 and 12 month). 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 NCT02539940, 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 10 Mar 2020.