Evaluation of the efficacy and safety of the MYNX CONTROL™ vascular closure device for achieving primary haemostasis after arterial femoral access following peripheral arterial interventions compared to the FemoSealTM vascular closure device
- Conditions
- I70.22
- Registration Number
- DRKS00031251
- Lead Sponsor
- niversitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 273
Inclusion Criteria
Patients with peripheral arterial interventions performed at the University Heart Centre Campus Bad Krozingen
Patients in whom the MYNX CONTROL™ or FemoSealTM closure system was used
Exclusion Criteria
Patients in whom no closure device or another closure device has been used
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of a significant complication at the puncture site defined as a complication resulting in medical treatment (vascular surgery, intervention, ultrasound-guided compression, thrombin injection, administration of blood products in case of bleeding at the puncture site)
- Secondary Outcome Measures
Name Time Method Predictors of closure device failure<br>Length of hospital stay<br>Haematoma >5cm in diameter at the puncture site without Hb drop<br>Haemorrhage from puncture site with Hb drop