Angiography, Angioplasty, Percutaneous Coronary Intervention
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEAxiostat®
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.
Sponsors
Axio Biosolutions Pvt. Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Hemostasis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Product Used | 1 Day | Number of Axiostat® required to achieve hemostasis. Unit of measurement is number. |
| Number of Patients With Re-bleeding | 1 Day | Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat |
| Number of Participants With Allergy/Skin Irritation and Hematoma Formation | Upto 2 Days | 1. Observing occurrence of Allergy/Skin Irritation at the puncture site 2. Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®. Mode of Measurement for both of the above outcomes is Visual Observation. Skin irritation/Allergy: Occurrence of redness at the puncture site was noted as skin irritation/allergy Hematoma: Hematoma formation at the puncture site. Hematoma was defined as presence of ecchymosis (the escape of blood into the tissues from ruptured blood vessels) at access site. |
| Ease of Use of Product | Upto 2 Days | Level of ease of use of Axiostat was recorded. The ease of application and removal of Axiostat was rated as Excellent or Good or Fair or Poor by the Clinician / Operator Mode of Measurement is Verbal Inquiry. |
| Patient Comfort Level | 1 day | Patients comfort level for use of dressing was recorded. The patient was required to rate the comfort level of use of dressing in terms of pain and swelling at the puncture site. It was assessed by verbal inquiry and visual observation. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Axiostat® Size: 3.5 cm X 3.5 cm
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. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Axiostat® | — |
|---|---|---|
| Age, Continuous Females | 56.35 years STANDARD_DEVIATION 9.17 | — |
| Age, Continuous Males | 55.94 years STANDARD_DEVIATION 12.23 | — |
| Baseline Blood Pressure Diastolic Blood Pressure | 81 mmHg STANDARD_DEVIATION 13 | — |
| Baseline Blood Pressure Systolic Blood Pressure | 136 mmHg STANDARD_DEVIATION 20 | — |
| Body Mass Index | 28.27 kg/m^2 STANDARD_DEVIATION 6.29 | — |
| Haemoglobin | 13.4 g/dl STANDARD_DEVIATION 1.37 | — |
| Prior History and Risk Factors Cardiogenic Shock | 1 Participants | — |
| Prior History and Risk Factors Diabetes | 24 Participants | — |
| Prior History and Risk Factors Hyperlipidemia | 2 Participants | — |
| Prior History and Risk Factors Hypertension | 41 Participants | — |
| Prior History and Risk Factors Prior Coronary Artery Bypass Graft | 1 Participants | — |
| Prior History and Risk Factors Prior Myocardial Infarction | 1 Participants | — |
| Prior History and Risk Factors Prior Percutaneous Coronary Intervention | 3 Participants | — |
| Prior History and Risk Factors Smoking | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment India | 70 Participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 53 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Time to Achieve Hemostasis
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.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axiostat® | Time to Achieve Hemostasis | 5.43 minutes | Standard Deviation 1.36 |
Secondary
Ease of Use of Product
Level of ease of use of Axiostat was recorded. The ease of application and removal of Axiostat was rated as Excellent or Good or Fair or Poor by the Clinician / Operator Mode of Measurement is Verbal Inquiry.
Time frame: Upto 2 Days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Axiostat® | Ease of Use of Product | Removal | Excellent | 13 Participants |
| Axiostat® | Ease of Use of Product | Application | Excellent | 15 Participants |
| Axiostat® | Ease of Use of Product | Application | Good | 52 Participants |
| Axiostat® | Ease of Use of Product | Application | Fair | 3 Participants |
| Axiostat® | Ease of Use of Product | Removal | Good | 57 Participants |
| Axiostat® | Ease of Use of Product | Removal | Fair | 0 Participants |
Secondary
Number of Participants With Allergy/Skin Irritation and Hematoma Formation
1. Observing occurrence of Allergy/Skin Irritation at the puncture site 2. Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®. Mode of Measurement for both of the above outcomes is Visual Observation. Skin irritation/Allergy: Occurrence of redness at the puncture site was noted as skin irritation/allergy Hematoma: Hematoma formation at the puncture site. Hematoma was defined as presence of ecchymosis (the escape of blood into the tissues from ruptured blood vessels) at access site.
Time frame: Upto 2 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Axiostat® | Number of Participants With Allergy/Skin Irritation and Hematoma Formation | 0 Participants |
Secondary
Number of Patients With Re-bleeding
Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Axiostat® | Number of Patients With Re-bleeding | 1 Participants |
Secondary
Patient Comfort Level
Patients comfort level for use of dressing was recorded. The patient was required to rate the comfort level of use of dressing in terms of pain and swelling at the puncture site. It was assessed by verbal inquiry and visual observation.
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Axiostat® | Patient Comfort Level | No swelling & pain | 59 Participants |
| Axiostat® | Patient Comfort Level | Minor swelling & pain | 11 Participants |
| Axiostat® | Patient Comfort Level | Tolerable swelling & pain | 0 Participants |
| Axiostat® | Patient Comfort Level | Intolerable swelling & pain | 0 Participants |
Secondary
Quantity of Product Used
Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axiostat® | Quantity of Product Used | 1 unit |