Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention

Completed

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01230606

Run by

Icahn School of Medicine at Mount Sinai

People needed

303

Starts

2008-01-01

Expected to finish

2010-06-01

Last updated by the study team

2011-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• . <75 years of age at the time of procedure.
• Patient has a type A or B lesion(s)
• Femoral access site is amenable to closure with a vascular closure device.
• Over 2 hours since the completion of the PCI procedure (at least 2 hours must elapse from completion of the PCI before subjects become eligible).

You may not qualify if…

• Patient has a life expectancy less than 12 months.
• Patient has recent evidence of an acute coronary syndrome (MI)
• Femoral access is difficult or site is not amenable to closure device
• Anticoagulants other than unfractionated heparin or bivalirudin were used during the procedure (i.e. enoxaparin).
• Patient has sub optimal angiographic outcome or clinical complication(s) during PCI
• The PCI occurred in something other than a native coronary artery
• Angiographic evidence of thrombus
• Patient has more than 3 stents implanted during this PCI
• Patient has an INR >2, Platelet count <100,000 or Hematocrit <25
• Occlusion of major side branch during PCI of >1.5mm
• Patient has ejection fraction ≤30%
• Known allergy to PCI procedural medications
• Patient reports living further than 30 minutes from a hospital by ambulance.
• Patient provides informed consent and agrees to the follow-up schedule.
• Evidence of vascular complication(s) (e.g. dissection, hematoma, bleeding) peri-procedure
• Patient is pregnant
• Evidence of infection (e.g. fever, pus, swelling) peri-procedure
• Patients with chronic renal insufficiency (e.g. serum creatinine ≥1.5 mg/dL)

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.