Status:
UNKNOWN
An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach
Lead Sponsor:
Klinikum Arnsberg
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05372952
Start Date
July 25 2022
End Date
August 1 2023
Last Update
January 26 2023
Active Locations (3)
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1
Vascular center of Klinikum Hochsauerland GmbH
Arnsberg, Germany, 59759
2
Oberlausitz Kliniken
Bautzen, Germany, 02625
3
Bonifatius Klinikum Lingen
Lingen, Germany, 49808