Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00474084
Status:
UNKNOWN
Last Update Posted:
2007-05-16
First Post:
2007-05-15
Brief Title:
Hydroxyapatite Active Pro Healing Clinical Trial Program
Sponsor:
BioSync Scientific Pvt Ltd
Organization:
BioSync Scientific Pvt Ltd
Study Overview
Official Title:
First In Man Evaluation of the Vesta VestaCOR Hydroxy-Apetite Coated genX Stent for Treatment of de Novo Native Coronary Artery Lesions
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
NOT_YET_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:
HApFIM
Brief Summary:
The purpose of this first feasibility study is to evaluate the performance of Vesta VestaCOR Hydroxy-Apetite coated GenX stent in de novo native coronary artery lesions This study will provide the longest follow-up experience available
This is a randomized double blind study conducted at three sites two sites in India and one in The Netherlands To be eligible a patient will be required to have a de novo stenotic lesion of a length that could be covered by a single stent in a native coronary artery of diameter 30mm and 35mm A total of at least 60 patients and a maximum of 70 patients will be treated with Vesta VestaCOR stent These patients will be randomized to either a smooth surface nanofilm coated stent VestaCOR approx 35 patients or to a porous coated stent Vesta approx 35 patients
All patients will be followed clinically at 30 days 4 months 9 months 1 2 3 4 and 5 years
This is a randomized double blind study conducted at three sites two sites in India and one in The Netherlands To be eligible a patient will be required to have a de novo stenotic lesion of a length that could be covered by a single stent in a native coronary artery of diameter 30mm and 35mm A total of at least 60 patients and a maximum of 70 patients will be treated with Vesta VestaCOR stent These patients will be randomized to either a smooth surface nanofilm coated stent VestaCOR approx 35 patients or to a porous coated stent Vesta approx 35 patients
All patients will be followed clinically at 30 days 4 months 9 months 1 2 3 4 and 5 years
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