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NCT01230606 · ClinicalTrials.gov registry record
Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 303
- Enrollment target
NCT01230606: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01230606 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 303 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230606 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 303 participants
- Enrollment target
Study Summary
This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24 hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and will have a study population of 600 patients over 6 investigational sites all within the United States. Patients \<65 years old will be chosen in order to stay within the low risk group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit. The primary endpoint will be a composite of major adverse cardiac and cerebral events, and the incidence of major bleeding or vascular complications. Data acquired from the study, such as blinded financial information and patient satisfaction surveys, will be used in order to evaluate cost analysis and safety of the procedure.
Primary Outcome
The primary endpoint is the difference in post-hospitalization patient satisfaction during the initial seven days following PCI. Post-hospitalization patient satisfaction will be assessed using the 10-item Post-Discharge Coping Difficulty scale.
Interventions
- OTHER discharge vs. overnight stay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-06 |
What the finished NCT01230606 record still lists
NCT01230606 is an observational study that tracks outcomes without assigning an intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which discharge vs. overnight stay is the first listed.
NCT01230606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230606 about?
NCT01230606 is a clinical study titled "Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention". This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24 hours after the procedure. Patients will...
What is the current status of trial NCT01230606?
This trial is currently completed. The enrollment target is 303 participants. The study started on 2008-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01230606?
The interventions under investigation include: discharge vs. overnight stay (OTHER).
Who is sponsoring clinical trial NCT01230606?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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