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

Klinikum Arnsberg

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Dynetic-35 Peripheral Balloon-Expandable Stent System

Study type: Observational

Funder types: Other

Identifiers

NCT05372952

ASL202201

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
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