I70.2
Conditions
Interventions
Group 1: Angiography and intervention will be performed either via transfemoral or transbrachial approach according to standard procedure. At the end of the procedure activated clotting time (ACT) wil
Sponsors
Medizinische Universitätsklinik Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subject with documented diagnosis of peripheral arterial disease (PAD) with indication for angiography and endovascular treatment 6-7F sheath usage Age = 18 years or minimum age as required by local regulations. Signed and dated Patient Informed Consent (PIC) form. Ability and willingness to comply with the clinical investigation plan (CIP). Life expectancy, in the Investigator’s assessment, of at least 12 months.
Exclusion criteria
Exclusion criteria: Age< 18 years Estimated life expectancy < 12 months High probability of non-adherence to CIP follow-up requirements Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/anti-platelet therapies, and/or paclitaxel. Known coagulation disorder No 6-7F sheath usage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from device failure, false aneurysm (aneurysma spurium), hematoma, arteriovenous- fistula, deep vein thrombosis, retroperitoneal haemorrhage within 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to hemostasis after sheath removement. | — |
Countries
Germany
Contacts
Public ContactMatthias Dufner
Universitätsklinikum Heidelberg, Medizinische Klinik, Klinik für Kardiologie, Angiologie und Pneumologie
Outcome results
None listed