Peripheral Artery DiseaseBIONETIC-INCT04830228
BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
An observational study of Peripheral Artery Disease, run by Biotronik AG at 15 sites in 6 countries.
Trial summary
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Ballon expandable stent and PTA
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 10 Aug 2021to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 will enroll subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo, restenotic and in-stent atherosclerotic lesions in iliac arteries
Who may be able to join
- Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
- Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
- Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
- De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
- Reference lumen (vessel) diameter between 5mm and 10mm
- The target lesion can be successfully crossed with a guide wire
Show all 10Show fewer
- The target lesion length is ≤ 100 mm
- Subjects has more than 70% stenosis in target lesion
- Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb
- Subject has symptomatic iliac artery occlusive disease defined as Rutherford category 2 or higher eligible for stenting
Who cannot join
- Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
- Subject is with a current medical condition with a life expectancy of less than one year.
- Pre-existing target iliac artery aneurysm or perforation or dissection
- Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
- Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
- The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
Show all 10Show fewer
- Refuses blood transfusion
- Chronic renal insufficiency (Serum creatinine >2.5 mg/dL within 30 days prior to index procedure)
- Subject has IFU listed contraindication(s)
- Subject has in-stent restenosis
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Germany6 sites
Klinikum Bayreuth
Bayreuth, 95445
Universitätsklinikum Essen
Essen
Diakonissenkrankenhaus
Flensburg, 24939
Universitätsklinikum Jena
Jena
St. Franziskushospital Münster
Münster, 48145
Universitätsklinikum Tübingen
Tübingen, 72076
Belgium4 sites
Zol Genk
Genk, 3600
UZ Gent
Ghent, 9000
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen
Az Jan Potaels Vilvoorde
Vilvoorde, 1800
France2 sites
Hôpital Privé du grand Narbonne
Narbonne, 11100
Hôpital Ambroise Paré
Paris
About this study
Official title: BIOTRONIK Dynetic-35 for the Treatment of Peripheral Iliac Lesions, Using the Cobalt Chromium Balloon-expandable Dynetic-35 Stent in Association With Passeo-35 Xeo Peripheral Dilation Catheter
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
Read the detailed description
Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries
- Conditions
- Peripheral Artery Disease
- Being tested
- Ballon expandable stent and PTA
- Keywords
- Iliac arteries
- 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.
Ballon expandable stent and PTADevice
Endovascular treatment for the peripheral artery disease of the Iliac artery
What is being measured
The primary outcome is the main question the study is designed to answer.
MAE at 12 months post-index procedure.
The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start10 Aug 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2028 (estimated)
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 Artery 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Brodmann, Prof. Dr., Principal investigator, Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830228
- Sponsor's protocol ID
- C1903
- Acronym
- BIONETIC-I
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brodmann M, Nemes B, Moreels N, Austermann M, Schmehl J, Robijn J, Rammos C, Muller-Hulsbeck S, Keirse K, Coscas R, Kupcs K, Augustin AM, Moebius-Winkler S, Lichtenberg M, Lansink W. Dynetic-35 cobalt chromium balloon-expandable stent for iliac lesions: 12-month results of the BIONETIC-I multi-center study. CVIR Endovasc. 2025 Dec 13;8(1):114. doi: 10.1186/s42155-025-00633-z.
PubMed 41389246
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK Dynetic-35 for the Treatment of Peripheral Iliac Lesions, Using the Cobalt Chromium Balloon-expandable Dynetic-35 Stent in Association With Passeo-35 Xeo Peripheral Dilation Catheter
- ClinicalTrials.gov ID
- NCT04830228
- Acronym / sponsor ID
- BIONETIC-I / C1903
- Conditions
- Peripheral Artery Disease
- Keywords
- Iliac arteries
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 5 Apr 2021 (actual)
- 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.
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
Detailed description
Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo, restenotic and in-stent atherosclerotic lesions in iliac arteries
Key inclusion criteria (10 listed)
- Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
- Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
- Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
- De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
- Reference lumen (vessel) diameter between 5mm and 10mm
Key exclusion criteria (10 listed)
- Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
- Subject is with a current medical condition with a life expectancy of less than one year.
- Pre-existing target iliac artery aneurysm or perforation or dissection
- Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
- Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
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 |
|---|---|---|
| Ballon expandable stent and PTAEndovascular treatment for the peripheral artery disease of the Iliac artery | Device | – |
Primary outcome
MAE at 12 months post-index procedure.
Time frame: 12 Months
The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 41389246Brodmann M, Nemes B, Moreels N, Austermann M, Schmehl J, Robijn J, Rammos C, Muller-Hulsbeck S, Keirse K, Coscas R, Kupcs K, Augustin AM, Moebius-Winkler S, Lichtenberg M, Lansink W. Dynetic-35 cobalt chromium balloon-expandable stent for iliac lesions: 12-month results of the BIONETIC-I multi-center study. CVIR Endovasc. 2025 Dec 13;8(1):114. doi: 10.1186/s42155-025-00633-z.
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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.
Marianne Brodmann, Prof. Dr. principal investigator
Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
15 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 Artery Disease, run by Biotronik AG at 15 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 10 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Belgium, France, Austria, Hungary 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?
This study is still under way. Results are not available in the source record yet.
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?
MAE at 12 months post-index procedure. (time frame: 12 Months). 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 NCT04830228, 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 12 Dec 2023.