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

NCT05372952 | Completed

• 1 other identifier: ASL202201
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

transradial access,

Outcome Measures

Primary Outcomes (5)

• Access site complications

  bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion

  1 hour post procedure

• Stroke

  30 days

• 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 Outcomes (5)

• Length of hospital stay [hours]

  up to 30 days

• Procedure time [min]

  Intraoperative

• Procedure cost

  1 hour post procedure

• Time to ambulation

  up to 30 days

• Patient satisfaction regarding access site

  24 hours post procedure

Interventions

Dynetic-35 Peripheral Balloon-Expandable Stent System DEVICE

Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from vascular center of the clinic.

You may qualify if:

• 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
• Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Klinikum Arnsberg: lead

Study Sites (1)

Vascular center of Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Michael H Lichtenberg, MD

  Klinikum Hochsauerland GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 13, 2022
• Study Start: July 25, 2022
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

DE (1)