Status:
COMPLETED
Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-75 years
Brief 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...
Detailed Description
Closure devices are a relatively new method for sealing the femoral arterial puncture following procedures including percutaneous intervention (PCI). Because the risk of severe complications (e.g., bl...
Eligibility Criteria
Inclusion
- . \<75 years of age at the time of procedure.
- 2\. Patient has a type A or B lesion(s)
- 3\. Femoral access site is amenable to closure with a vascular closure device.
- 4\. 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).
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01230606
Start Date
January 1 2008
End Date
June 1 2010
Last Update
July 28 2011
Active Locations (2)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029
2
Baylor University Medical Center
Dallas, Texas, United States, 75226