Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419055
Status:
TERMINATED
Last Update Posted:
2012-04-02
First Post:
2007-01-04
Brief Title:
Outpatient Percutaneous Coronary Intervention
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Outpatient Percutaneous Coronary Intervention in a Selected Stable Patient Population
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped early due to inability to recruit full 100 subjects over 2 years
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention early discharge is safe and feasible
Detailed Description:
A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel During PCI patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device Patients that stay overnight in the hotel must be accompanied by a family member They return to the cath lab the next day for groin check and blood work Satisfaction questionnaires are filled out by all patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None