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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031251
Enrollment
250
Registered
2023-06-22
Start date
2023-02-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I70.22

Interventions

Group 1: Retrospective monocentric data analysis after use of the Mynx closure device to achieve primary haemostasis, and comparison of results with FemoSeal closure device used during the same period

Sponsors

Universitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria: Patients in whom no closure device or another closure device has been used

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Predictors of closure device failure Length of hospital stay Haematoma >5cm in diameter at the puncture site without Hb drop Haemorrhage from puncture site with Hb drop—

Countries

Germany

Contacts

Public ContactThomas Zeller

Universitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg

thomas.zeller@uniklinik-freiburg.de076334022431

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026