Study on Medical Device.

Not Applicable

Completed

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

• Registration Number: CTRI/2021/03/032112
• Lead Sponsor: The Madras Medical Mission Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Patients meeting with following criteria to be included in the study:

1) Patients aged 18 years and above of both gender.

2) Patients scheduled to undergo PCI procedure through femoral access site route.

3) Acute Coronary Syndrome patients who were administered therapeutic thrombolytic agents 12 to 24 hours before PCI procedure.

4) In the Investigatorââ?¬•s opinion, patient is suitable for the Angio-SealTM vascular closure device or conventional hemostasis technique (manual compression) and participation in the clinical study.

5) 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 or lactating women.

2)Patients with Systemic infection or a local infection at or near the access site.

3)Patients with significant anemia (hemoglobin <30%).

4)Patients in whom oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure.

5)Patients with known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease

6)Patient who have an allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel

7)Patients with renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy

8)Patients who have undergone unilateral or bilateral lower extremity amputation.

9)Prior vascular surgery or vascular graft in region of access site.

10)Prior target artery closure with a vascular closure device having intravascular component 30 days prior to catheterization.

11)Patients with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure

12)Patients who are infected with COVID-19 at the time of enrolment as determined by the standard COVID-19 infection screening protocols followed by the clinical study site (hospital).

13)Presence of any other clinically significant disease or laboratory findings that in the Investigatorââ?¬•s opinion may affect the study outcomes.

14)Participation in another study concurrently or within 4 weeks prior to the Screening Visit.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the time to hemostasis (TTH) between groups (hemostasis is defined as elapsed time between device removal and first observed and confirmed arterial hemostasis)Timepoint: At puncture closure just after procedure (at baseline).

Secondary Outcome Measures

Name	Time	Method
1)Time to ambulation (TTA. <br/ ><br>2)Time to hospital discharge (TTD). <br/ ><br>3)Vascular access site complications other than hematoma. <br/ ><br>4)VCD Failure <br/ ><br>5)Evaluate the incidence of access site hematomas between groups. <br/ ><br>6)Pharmacoeconomic analysis. <br/ ><br>7)Adverse events (AE) or serious adverse events (SAE). <br/ ><br>8)PCI procedural complications. <br/ ><br>9)Mortality rate.Timepoint: 1)Upto 48 hours following the completion of the procedure. <br/ ><br>2) From end of vessel closure procedure to 30 days post-procedure.