CompletedNot Applicable

An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach

Germany25 participantsStarted 2022-07-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. The target lesion can be successfully crossed with a guide wire
. Patient is eligible for transradial access

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Access site complications

Timeframe: 1 hour post procedure

Stroke

Timeframe: 30 days

Death

Timeframe: 30 days

Transradial technical success

Timeframe: Immediately after stent placement via radial access

Number of patients converting to femoral artery access

Timeframe: 1 hour post procedure

Trial details

NCT IDNCT05372952

SponsorKlinikum Arnsberg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-03

View on ClinicalTrials.gov More Peripheral Arterial Disease trials