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

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 Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Dynetic-35 Peripheral Balloon-Expandable Stent System

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Vascular center of Klinikum Hochsauerland GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients from vascular center of the clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke		30 days
Access site complications	bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion	1 hour post procedure
Death		30 days
Transradial technical success	Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30%	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	1 hour post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay [hours]		up to 30 days
Procedure time [min]		Intraoperative
Procedure cost	Number and details of auxiliary devices and medication used	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	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).	24 hours post procedure

Collaborators and Investigators

• Sponsor: Klinikum Arnsberg
• Investigators: Principal Investigator: Michael H Lichtenberg, MD, Klinikum Hochsauerland GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): June 3, 2025
• Study Completion (Actual): June 3, 2025

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: transradial access,
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: ASL202201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No