Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure (AHD)

Axio Biosolutions

Status

Completed

Conditions

Angiography

Percutaneous Coronary Intervention

Angioplasty

Treatments

Device: Axiostat®

Study type

Observational

Funder types

Other

Identifiers

NCT02837744

CTRI/2016/07/007115 (Registry Identifier)

ABPL/002

U1111-1185-5780 (Other Identifier)

Details and patient eligibility

About

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.

Full description

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age greater than or equal to 18 years.
Patient and/or patient's legal representative and/or impartial witness has/have been informed of the nature of the study and agrees to its provision and has provided written informed consent as approved by the Ethics Committee of the investigative site.
Iatrogenic puncture
Patient who want to undergo radial intervention.
All puncture size must be less than 2.5cm.

Exclusion criteria

Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).
Patients with known sensitivity to chitosan (shellfish) used in this study.
Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.
Patient is currently participating in an investigational drug or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this trial.
Pregnant women.
Patients with hemorrhagic shock.
Patient having hemoglobin < 9 g/dl.