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Clinical Trials/CTRI/2019/05/019033
CTRI/2019/05/019033OtherPhase 4

An Investigator Initiated, open label, single centre, double arm, placebo controlledrandomized 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

Gp Capt Dr V Anand0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Other
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Pms

Eligibility 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

  • •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

Investigators

Sponsor
Gp Capt Dr V Anand

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