Peripheral Arterial DiseaseNCT05372952
An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach
An observational study of Peripheral Arterial Disease, run by Klinikum Arnsberg at 1 site in Germany.
Trial summary
This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach. 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?
- Dynetic-35 Peripheral Balloon-Expandable Stent System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2022to 3 Jun 2025
- 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 from vascular center of the clinic.
Who may be able to join
- Subject is ≥ 18 years
- 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
- Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
- Target lesion is a de novo, restenotic or occluded lesion
- Reference lumen (vessel) diameter between 5mm and 10 mm
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- The target lesion can be successfully crossed with a guide wire
- Patient is eligible for transradial access
- Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher
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
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- Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
- Severe stenosis or calcification of upper extremity arteries
- Patient height precluding transradial access with a 170 cm long catheter shaft
- Patient with a history of aortic arch atheroembolism
- Infrainguinal outflow lesions that need to be treated during the same index procedure
- Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
- Subject has IFU listed contraindication(s)
- Subject has in-stent restenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Cobalt Chromium Balloon-expandable Stent for the Treatment of Atherosclerotic Iliac Lesions Via a Trans-radial Approach - Bionetic-TRA
This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Dynetic-35 Peripheral Balloon-Expandable Stent System
- Keywords
- transradial access,
- 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.
Dynetic-35 Peripheral Balloon-Expandable Stent SystemDevice
Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access
What is being measured
The primary outcome is the main question the study is designed to answer.
Access site complications
bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion
Measured: 1 hour post procedure
Stroke
Measured: 30 days
Death
Measured: 30 days
Transradial technical success
Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30%
Measured: Immediately after stent placement via radial access
Number of patients converting to femoral artery access
Transradial access feasibility is assessed as number of patients in whom access is converted to femoral artery access due to failure to access the lesion via the radial artery
Measured: 1 hour post procedure
Secondary outcomes (5)
Length of hospital stay [hours]
Measured: up to 30 days
Procedure time [min]
Measured: Intraoperative
Procedure cost
Number and details of auxiliary devices and medication used
Measured: 1 hour post procedure
Time to ambulation
Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable
Measured: up to 30 days
Patient satisfaction regarding access site
Patient questionnaire assessing 8 questions (anxiety about the procedure, overall pain, back pain, difficulties in toiletting, walking, daily movement, selfcare and using the dominant hand) on a numeric rating scale (NRS, 0-10, 0 = none, 10 most severe).
Measured: 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start25 Jul 2022
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Arnsberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Lichtenberg, MD, Principal investigator, Klinikum Hochsauerland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372952
- Sponsor's protocol ID
- ASL202201
- Status last verified
- Jan 2026
- First submitted
- 2 May 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Cobalt Chromium Balloon-expandable Stent for the Treatment of Atherosclerotic Iliac Lesions Via a Trans-radial Approach - Bionetic-TRA
- ClinicalTrials.gov ID
- NCT05372952
- Acronym / sponsor ID
- ASL202201
- Conditions
- Peripheral Arterial Disease
- Keywords
- transradial access,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Klinikum ArnsbergUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 13 May 2022 (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.
This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from vascular center of the clinic.
Key inclusion criteria (9 listed)
- Subject is ≥ 18 years
- 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
- Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
- Target lesion is a de novo, restenotic or occluded lesion
Key exclusion criteria (14 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 |
|---|---|---|
| Dynetic-35 Peripheral Balloon-Expandable Stent SystemStenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access | Device | – |
Primary outcome
Access site complications
Time frame: 1 hour post procedure
bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion
Stroke
Time frame: 30 days
Death
Time frame: 30 days
Transradial technical success
Time frame: Immediately after stent placement via radial access
Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30%
Number of patients converting to femoral artery access
Time frame: 1 hour post procedure
Transradial access feasibility is assessed as number of patients in whom access is converted to femoral artery access due to failure to access the lesion via the radial artery
5 secondary outcomes
Length of hospital stay [hours]
Time frame: up to 30 days
Procedure time [min]
Time frame: Intraoperative
Procedure cost
Time frame: 1 hour post procedure
Time to ambulation
Time frame: up to 30 days
Patient satisfaction regarding access site
Time frame: 24 hours post procedure
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 23 Jan 2026.
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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.
Michael H Lichtenberg, MD principal investigator
Klinikum Hochsauerland GmbH
1 site in 1 country: 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 Klinikum Arnsberg at 1 site 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 14 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Access site complications (time frame: 1 hour post procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.