Study on Medical Device

Not Applicable

Conditions: Health Condition 1: I779- Disorder of arteries and arterioles, unspecified

Registration Number: CTRI/2021/05/033309

Lead Sponsor: Aditya Birla Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Discharge post procedure in hours (Clinicians prescription notes will be taken as Discharge pointTimepoint: At baseline

Secondary Outcome Measures

Name	Time	Method
1) Incidence of vascular access site complications i.e. composite of hematoma, pseudoaneurysm, arteriovenous fistula <br/ ><br>2) Time to ambulation <br/ ><br>3) Time to haemostasis <br/ ><br>Timepoint: Post Procedure