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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Percutaneous Coronary Intervention Angiography Angioplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Axiostat®

Size: 3.5 cm X 3.5 cm

Axiostat®

Intervention Type DEVICE

Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.

Interventions

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Axiostat®

Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.

Intervention Type DEVICE

Other Intervention Names

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Hemostatic Dressing

Eligibility Criteria

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Inclusion Criteria

1. Age greater than or equal to 18 years.
2. 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.
3. Iatrogenic puncture
4. Patient who want to undergo radial intervention.
5. All puncture size must be less than 2.5cm.

Exclusion Criteria

1. Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).
2. Patients with known sensitivity to chitosan (shellfish) used in this study.
3. Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.
4. 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.
5. Pregnant women.
6. Patients with hemorrhagic shock.
7. Patient having hemoglobin \< 9 g/dl.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes