A clinical study to assess safety and efficacy of Velseal-T as haemostatic device after angioplasty/angiography compared to standard dressing.
- Conditions
- Health Condition 1: I998- Other disorder of circulatory system
- Registration Number
- CTRI/2019/05/019033
- Lead Sponsor
- Gp Capt Dr V Anand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1. Males and females undergoing for angiography/ angioplasty.
2. Male and female of age between 18 to 85 years.
3. Subject who can provide informed consent form in written.
4. Subjects allowing their data to be collected for the study at predefined follow-ups.
1. Subject presented with medical emergency, where treatment is priority than the
informed consent process.
2. Subject or their LAR not able to provide informed consent in written.
3. Subject unwilling or unable to comply with the postoperative follow-ups necessary for
data collection.
4.Subjects with known hemorrhagic disorders like GI bleeding, Ante partum Haemorrhage,
Metropathia Haemorragica, History of Haematemesis, Haematuria, Epistaxis etc.
5.Subject with Genetic bleeding disorder.
6.Subjects with known possible loss of plasma or blood from other areas than wound such
as lacerations, Uterine bleeding, Gastro-intestinal bleeding etc.
7.The subject with an active infection at the site.
8.Subjects with evidence of bleeding or haematoma at the access site prior to sheath
removal.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method