Percutaneous Coronary InterventionAHDNCT02837744
Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
An observational study of Percutaneous Coronary Intervention and Angiography, run by Axio Biosolutions Pvt. Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Coronary Intervention, Angiography, Angioplasty
- What is being tested?
- Axiostat®
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2016to Nov 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible patients who came to the institution/hospital and provided informed consent.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola
Ahmedabad, Gujarat, 380060
About this study
Official title: Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention, Angiography, Angioplasty
- Being tested
- Axiostat®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axiostat®Device
Also called Hemostatic Dressing
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.
| Study group | Role | What they receive |
|---|---|---|
| Axiostat® | Size: 3.5 cm X 3.5 cm Receives: Device: Axiostat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Day
Secondary outcomes (5)
Quantity of Product Used
Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.
Measured: 1 Day
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
Measured: 1 Day
Number of Participants With Allergy/Skin Irritation and Hematoma Formation
- Observing occurrence of Allergy/Skin Irritation at the puncture site
- 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.
Measured: Upto 2 Days
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.
Measured: Upto 2 Days
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axio Biosolutions Pvt. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milan Chag, Dr., Principal investigator, Care Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837744
- Sponsor's protocol ID
- ABPL/002
- Other IDs
- U1111-1185-5780, CTRI/2016/07/007115
- Acronym
- AHD
- Status last verified
- Feb 2021
- First submitted
- 11 Jul 2016
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure
- ClinicalTrials.gov ID
- NCT02837744
- Acronym / sponsor ID
- AHD / ABPL/002
- Conditions
- Percutaneous Coronary Intervention, Angiography, Angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Axio Biosolutions Pvt. Ltd.University, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axiostat® | – | Device: Axiostat®Size: 3.5 cm X 3.5 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients who came to the institution/hospital and provided informed consent.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axiostat®Also: Hemostatic DressingAxiostat 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. | Device | Axiostat® |
Primary outcome
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.
5 secondary outcomes
Quantity of Product Used
Time frame: 1 Day
Number of Patients With Re-bleeding
Time frame: 1 Day
Number of Participants With Allergy/Skin Irritation and Hematoma Formation
Time frame: Upto 2 Days
Ease of Use of Product
Time frame: Upto 2 Days
Patient Comfort Level
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Chag, Dr. principal investigator
Care Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention and Angiography, run by Axio Biosolutions Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve Hemostasis (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.