I70.2
Conditions
Interventions
Group 1: All PAD patients >18 Jahre who receive a PTA of the iliac arteries will be asked to participate in the clinical trial.
If the patient decides to participate in the study after the medical con
Sponsors
Elblandklinikum Radebeul
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients > 18 years 2. Patient has been informed about the type of study, duration and follow-up examination and has signed the informed consent 3. Reference vessel diameter (RVD) of the radial artery suitable for 6F access (sonographically determined) 4. Openness of the radial artery and ulnar artery (sonographically determined) 5. De-novo or restenotic lesion with > 70% stenosis (as assessed by the examiner) of the iliac arteries 6. Lesion is suitable for PTA or stenting 7. Rutherford Category 2-6
Exclusion criteria
Exclusion criteria: 1. Patients < 18 years 2. Participation in another drug, medical device or biological study 3. Acute vascular occlusions 4. Acute myocardial infarction < 30 days before the index procedure 5. Acute stroke < 30 days before the index procedure 6. Pregnant or breastfeeding patients 7. Life expectancy < 1 year 8. Patients with previous aortic arch embolisms or aortic arch procedures 9. Patients with sonographically confirmed occlusion of the radial artery or ulnar artery 10. Aneurysms in the target vessel 11. ASA/clopidogrel intolerance 12. Rutherford Category 0-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primarily transradial technical success: - successful intervention with balloon/stent with < 30% residual stenosis (according to visual assessment of the examiner) - Frequency of access route changes | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications at the puncture site (24h and 1 month post-interventional): - Bleeding, pseudoaneurysms, arteriovenous fistulas, radial ruptures or occlusions Absence of stroke and procedure-related death (30 days) Duration of intervention Fluoroscopy time Length of hospital stay Cost of the intervention Improvement of subjective quality of life compared to Baseline and follow-up using the Vascular Quality of Life Questionnaire (VascuQoL-6) Change in subjective pain perception before and after Procedure using Numeric Rating Scale (NRS) | — |
Countries
Germany
Contacts
Public ContactTorsten Fuß
Elblandklinikum Radebeul
Outcome results
None listed