Wrist-Access stent shows promise for leg artery blockages
NCT ID NCT05372952
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a new stent (Dynetic-35) can safely open blocked arteries in the leg when inserted through the wrist instead of the groin. Twenty-five people with peripheral artery disease took part, and the main goal was to see if the procedure was safe and feasible. The study lasted 30 days and focused on complications and technical success.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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25 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients from vascular center of the clinic.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is ≥ 18 years 2. 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 3. 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 4. Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries 5. Target lesion is a de novo, restenotic or occluded lesion 6. Reference lumen (vessel) diameter between 5mm and 10 mm 7. The target lesion can be successfully crossed with a guide wire 8. Patient is eligible for transradial access 9. Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher Exclusion Criteria: 1. Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study. 2. Subject is with a current medical condition with a life expectancy of less than one year. 3. Pre-existing target iliac artery aneurysm or perforation or dissection 4. 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 5. Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment 6. The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet 7. Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath 8. Severe stenosis or calcification of upper extremity arteries 9. Patient height precluding transradial access with a 170 cm long catheter shaft 10. Patient with a history of aortic arch atheroembolism 11. Infrainguinal outflow lesions that need to be treated during the same index procedure 12. Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible) 13. Subject has IFU listed contraindication(s) 14. Subject has in-stent restenosis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vascular center of Klinikum Hochsauerland GmbH
Arnsberg, 59759, Germany
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