N/A
N=70
Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Percutaneous Coronary Intervention · Angiography · Angioplasty
Bottom Line
View on ClinicalTrials.gov: NCT02837744 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Time to Achieve Hemostasis — 5.43 minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Axiostat® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Axio Biosolutions Pvt. Ltd.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Achieve Hemostasis |
5.43 | — |
| SECONDARY Quantity of Product Used |
1 | — |
| SECONDARY Number of Patients With Re-bleeding |
1 | — |
| SECONDARY Number of Participants With Allergy/Skin Irritation and Hematoma Formation |
— | — |
| SECONDARY Ease of Use of Product |
15; 52; 3; 13; 57; 0 | — |
| SECONDARY Patient Comfort Level |
59; 11; 0; 0 | — |
Summary
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02837744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.