Status:
UNKNOWN
Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
Lead Sponsor:
Clearstream Technologies Ltd.
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study. A total of 40 patients wi...
Eligibility Criteria
Inclusion
- Clinical
- \>18 years of age,
- symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but \<48 h
- Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board
- Angiographic
- reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate)
- discrete target lesion (maximum length of 28 mm by visual estimation)
- target lesion is in a native coronary artery
- presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter.
Exclusion
- Clinical
- previously documented left ventricular ejection fraction of less than 30%
- estimated life expectancy of less than 12 months
- a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
- participation in another study
- inability to give informed consent owing to prolonged cardiopulmonary resuscitation
- and dominant Renal impairment (serum creatinine \> 2.0 mg/dl) Angiographic
- non-culprit lesion located in the proximal LAD or in a proximal and dominant Circumflex artery
- previous PCI of the target vessels restenosis or stent thrombosis as culprit lesion
- unprotected left main coronary artery disease
- non-culprit lesion located in a vein graft
- severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00914420
Start Date
June 1 2009
End Date
October 1 2012
Last Update
April 19 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Modena
Modena, Italy