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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynetic-35 Peripheral Balloon-Expandable Stent System | Device | Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay [hours] | up to 30 days | |
| Procedure time [min] | Intraoperative | |
| Procedure cost |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from vascular center of the clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Lichtenberg, MD | Klinikum Hochsauerland GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular center of Klinikum Hochsauerland GmbH | Arnsberg | 59759 | Germany |
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Number and details of auxiliary devices and medication used
| 1 hour post procedure |
| Time to ambulation | Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable | up to 30 days |
| Patient satisfaction regarding access site | 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). | 24 hours post procedure |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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