An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent fo… (NCT05372952) | Clinical Trial Compass
CompletedNot Applicable
An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach
Germany25 participantsStarted 2022-07-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Access site complications
Timeframe: 1 hour post procedure
2
Stroke
Timeframe: 30 days
3
Death
Timeframe: 30 days
4
Transradial technical success
Timeframe: Immediately after stent placement via radial access
5
Number of patients converting to femoral artery access
✕. 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