Ignite Creation Date:
2024-05-05 @ 9:33 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00914420
Status:
UNKNOWN
Last Update Posted:
2010-04-19
First Post:
2009-06-03
Brief Title:
Optical Coherence Tomography OCT Evaluation of Re-endothelization A Comparison of the Intrepide Stent Versus Taxus
Sponsor:
Clearstream Technologies Ltd
Organization:
Clearstream Technologies Ltd
Study Overview
Official Title:
OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes a Comparison of the Intrepide Stent vs Taxus
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OISTER
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 will be randomized 20 of them will receive a Trapidil eluting stent Intrepide stent 20 will receive a Paclitaxel eluting stent Taxus stent After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion
Coronary angiography will be performed through the femoral groin or radial wrist artery with the use of standard techniques The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram
A total of 40 patients will be randomized 20 of them will receive a Trapidil eluting stent Intrepide stent 20 will receive a Paclitaxel eluting stent Taxus stent After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion
Coronary angiography will be performed through the femoral groin or radial wrist artery with the use of standard techniques The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None