Peripheral Arterial Disease
Conditions
Keywords
transradial access,
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.
Interventions
DEVICEDynetic-35 Peripheral Balloon-Expandable Stent System
Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access
Sponsors
Klinikum Arnsberg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access site complications | 1 hour post procedure | bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion |
| Stroke | 30 days | — |
| Death | 30 days | — |
| Transradial technical success | Immediately after stent placement via radial access | Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30% |
| Number of patients converting to femoral artery access | 1 hour post procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay [hours] | up to 30 days | — |
| Procedure time [min] | Intraoperative | — |
| Procedure cost | 1 hour post procedure | Number and details of auxiliary devices and medication used |
| Time to ambulation | up to 30 days | Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable |
| Patient satisfaction regarding access site | 24 hours post procedure | 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). |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORMichael H Lichtenberg, MD
Klinikum Hochsauerland GmbH
Outcome results
None listed