A clinical study to assess safety and efficacy of Velseal-T as haemostatic device after angioplasty/angiography compared to standard dressing.

An Investigator Initiated, open label, single centre, double arm, placebo controlled randomized study to evaluate safety and efficacy of VELSEAL-T as haemostatic medical device as an adjunct to manual compression to reduce time to haemostasis after angioplasty/ angiography

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/05/019033

Enrollment

186

Registered

2019-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I998- Other disorder of circulatory system

Interventions

Intervention1: Velseal-T: Haemostatic Medical Device. VELSEAL-T is an innovative haemostatic medical device for bleeding control

it consists of clotting agent (Thrombin) and anti-fibrinolytic agent (Tranexamic Acid). These constituents are held on the internal surface of VELSEAL-T, which enables the rapid coagulation when blood

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of the VELSEAL - T haemostatic medical device as an adjunct to manual compression w.r.t. placebo to reduce haemostasis time after angioplasty/ angiography.Timepoint: within 5-20 minutes of study device application	—

Secondary

Measure	Time frame
1) Assessment of VELSEAL-T success (defined as the time to haemostasis (within 15 minutes) in the patients after angioplasty/ angiography as an adjunct to manual compression). 2) Assessment of VELSEAL-T related adverse events.Timepoint: at 20mins,2hrs,4hrs & 24hrs	—

Countries

India

Contacts

Public ContactGp Capt Dr V Anand

Army Hospital Research & Referral

vembuanand@yahoo.com8800878685

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026