Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299026
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2006-03-03
Brief Title:
A Randomized Double-Blind Controlled Study of the Safety and Performance of the NIRx Paclitaxel-Coated Conformer Coronary Stent
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
TAXUS II A Randomized Double-Blind Controlled Study of the Safety and Performance of the NIRx Paclitaxel-Coated Conformer Coronary Stent
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
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:
None
Brief Summary:
The clinical investigation is an international prospective double-blind randomized safety and efficacy study The purpose of this study is to evaluate the safety and performance of the NIRxTM Paclitaxel-Coated Stent 10µgmm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier systemin patients who present for stenting of de novo lesions of a native coronary artery
Detailed Description:
The primary objective of this study is to evaluate the safety and performance of coronary artery stenting with the NIRxTM Paclitaxel-Coated Stent 10µgmm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system for the treatment of de novo lesions in native vessels Patients in 2 sequential cohorts will be randomised to receive either the NIRxTM Paclitaxel-Coated Stent or the uncoated control stent In cohort 1 the slow-release formulation NIRxTM Paclitaxel-Coated Stent will be studied If the safety profile is acceptable the moderate-release formulation NIRxTM Paclitaxel-Coated Stent will be studied in Cohort 2 In each f the 2 cohorts 133 patients will be treated with the NIRxTM paclitaxel-Coated Stent and 133 with the uncoated control stent 11 ratio for a total of 532 patients in study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S2003 | None | None | None |