Status:
COMPLETED
EArly Discharge After Transradial Stenting of CoronarY Arteries: The EASY Study
Lead Sponsor:
Laval University
Collaborating Sponsors:
Eli Lilly and Company
Bristol-Myers Squibb
Conditions:
Coronary Artery Disease
Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
HYPOTHESES * Discharge on the same day after uncomplicated trans-radial coronary artery stenting is safe and effective. * Hospitalized patients can be safely returned to the referring center the same...
Detailed Description
Despite significant improvements in clinical results associated with the current use of stenting and pharmacologic agents there has been little modification in hospitalization duration after percutane...
Eligibility Criteria
Inclusion
- Patients with documented ischemic coronary artery disease and scheduled for possible coronary artery stenting are eligible.
- Patient must be \> 18 years of age.
- Patient and treating interventional cardiologist agree for randomization.
- Patient will be informed of the randomization process and will sign an informed consent.
- Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
Exclusion
- CLINICAL:
- Patients with recent (\< 72 hrs) Q-wave (ST elevation) acute myocardial infarction.
- History of LV ejection fraction ≤ 30%.
- Unstable clinical condition.
- Any complication compromising ambulation
- Concurrent participation in other investigational study requiring prolonged hospitalization
- Required prolonged hospitalization
- In-cath lab transient vessel closure
- Resuscitation per PCI
- Hemodynamic collapse during PCI
- Severe entry site complication upon investigator decision
- Social isolation
- Serious cognitive disorders
- Femoral sheath (artery)
- Persisting chest pain
- No ASA prior PCI
- Allergy to ASA or thienopyridines precluding treatment for 30 days
- Any significant blood dyscrasia
- PCI without stent implantation (except for bifurcation lesion or re-dilatation for in-stent restenosis)
- International Normalised Ratio (INR) \> 2.0
- Contraindication to Reopro administration
- ANGIOGRAPHIC
- Residual dissection of grade ≥ B of NHBLI classification.
- Compromised or sub-occluded branch with diameter ≥ 1 mm.
- Timi \< 3 post-stenting
- Thrombus post-PCI
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00169819
Start Date
October 1 2003
End Date
April 1 2006
Last Update
February 26 2007
Active Locations (1)
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1
Laval Hospital Research Center
Sainte-Foy, Quebec, Canada, G1V 4G5