coronary angiography
Conditions
Interventions
Group 1: manual kompression with a following pressure bandage
Group 2: internal closure system (ExoSeal, Cordis)
Group 3: external compression adhesive dressing (Safeguard, Maquet)
Sponsors
HBK-Kliniken Singen, Akademisches Lehrkrankenhaus der Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: BMI (body mass index) = 30 kg / m² • the common femoral artery puncture • Diagnostic angiography or coronary intervention with a 5F or 6F introducer sheath • age of the patient = 18 • Signed Informed Consent and Privacy
Exclusion criteria
Exclusion criteria: • At least one inclusion criterion does not apply • Uncontrolled blood pressure with RR> 180/110mmHg • Previous vascular surgery or femoral bypass surgery • Previous femoral or iliac vascular intervention • Former femoral vascular closure with internal closure system (eg AngioSeal, CoStar) • Heavily calcified or atheromtös modified femoral artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comb. endpoint of complications at the bar after puncturing the femoral artery (hematoma = 5 cm, Aneurymsa spurium, bleeding with hemoglobin decrease = 2mg/dl, transfusion requirement, retroperitoniale hemorrhage, pressure ulcer = grade 2, ischemia of the ipsilateral lower extremity, nerve injury within 48 hours, after 7 and 31 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematomas <5cm, bleeding with hemoglobin drop <2mg/dl, abrasion of the skin, pressure ulcer grade 1, prolonged tourniquet time, prolonged hospitalisation, fever within 24 hours after surgery, local infection of the puncture, the patient's pain, feeling of patient safety, patient comfort , user satisfaction within 48 hours and after 7 and 31 days. | — |
Countries
Germany
Contacts
Public ContactStefan Köberich
Universitätsklinikum Freiburg, Medizin III
Outcome results
None listed