Health Condition 1: I779- Disorder of arteries and arterioles, unspecified
Conditions
Interventions
None listed
Sponsors
Aditya Birla Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting with following criteria to be included in the study: 1) Patients > 18 years of age 2) Patients suitable for percutaneous coronary intervention through femoral approach 3) Angio-Seal • deployment will be as the IFU approved for India. 4) Patient or Legally acceptable representative of patient willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in the study
Exclusion criteria
Exclusion criteria: Patients meeting with following criteria to be excluded from the study: 1) Pregnant/ lactating females 2) Patients having known allergy to collagen and/or collagen products, or polyglycolic or polylactic acid polymers 3) Patients with ST elevation MI 4) Patients with Heart failure 5) Presence of any other clinically significant disease or laboratory findings that in the Investigatorâ??s opinion may affect the study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Discharge post procedure in hours (Clinicians prescription notes will be taken as Discharge pointTimepoint: At baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of vascular access site complications i.e. composite of hematoma, pseudoaneurysm, arteriovenous fistula 2) Time to ambulation 3) Time to haemostasis Timepoint: Post Procedure | — |
Countries
India
Contacts
Public ContactDr Rajesh Surendra Badani
Aditya Birla Memorial Hospital
Outcome results
None listed