Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure (AHD)
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|ClinicalTrials.gov Identifier: NCT02837744|
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment|
|Percutaneous Coronary Intervention Angiography Angioplasty||Device: Axiostat®|
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Size: 3.5 cm X 3.5 cm
Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site.
Other Name: Hemostatic Dressing
- Time to achieve hemostasis [ Time Frame: 1 Day ]
Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.
Unit of measurement is minutes:seconds.
- Number of patients with hemostasis;number of patients with rebleeding [ Time Frame: 1 Day ]
Number of patients will be counted (unit of measurement is number/count of patients)
- Number of patients with hemostasis
- Number of patients with rebleeding after removal of Axiostat
- Quantity of Product used [ Time Frame: 1 Day ]Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.
- Skin Irritation & & Formation of Hematoma [ Time Frame: Upto 2 Days ]
(1)Observing Allergy/Skin Irritation (2))Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®.
Mode of Measurement is Visual Observation.
- Ease of use of Product & Patient Comfort Level [ Time Frame: Upto 2 Days ]
- Patients comfort level as assessed by verbal inquiry after completion of procedure.
- Level of ease of use of product. Mode of Measurement is Verbal Inquiry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837744
|Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola|
|Ahmedabad, Gujarat, India, 380060|
|Principal Investigator:||Milan Chag, Dr.||Care Institute of Medical Sciences|