A Real-world, prospective, observational, investigator-initiated study to evaluate the patient outcomes with Angio-SealTM femoral closure device as compared to manual compression in patients who are undergoing Percutaneous Coronary Intervention.

The Madras Medical Mission Hospital0 sites90 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Health Condition 1: I779- Disorder of arteries and arterioles, unspecified
Sponsor: The Madras Medical Mission Hospital
Enrollment: 90
Status: Completed
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 23, 2021

Last Updated

3 years ago

Study Type

Observational

Sponsor

The Madras Medical Mission Hospital

•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 InvestigatorÃ¢â?¬•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.

•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.