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

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

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

NCT05372952•Klinikum Arnsberg

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Vascular center of Klinikum Hochsauerland GmbH

Arnsberg, Germany

Key Dates

Start Date

July 25, 2022

Primary Completion Date

June 3, 2025

Completion Date

June 3, 2025

Last Updated

January 23, 2026

Enrollment

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

Dynetic-35 Peripheral Balloon-Expandable Stent System

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

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