A prospective randomized Trial to evaluate the Complication rate and patients´ comfort using three different vascular closure strategies following coronary angiography.
Not Applicable
- Conditions
- coronary angiography
- Registration Number
- DRKS00000802
- Lead Sponsor
- HBK-Kliniken SingenAkademisches Lehrkrankenhaus der Universitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 250
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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comb. endpoint of complications at the bar after puncturing the femoral artery (hematoma = 5 cm,<br> 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<br><br>
- Secondary Outcome Measures
Name Time Method 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.