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