Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
Study NCT ID:
NCT00739466
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2008-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
Sponsor:
BIOrest Ltd.
Organization:
Study Overview
Official Title:
Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation
Status:
COMPLETED
Status Verified Date:
2016-01
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:
BLAST
Brief Summary:
The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare metal stent.
Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to placebo.
Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to placebo.
Detailed Description:
This is a Phase II dose-finding, randomized, multi-center, prospective, double blind clinical study. Subjects undergoing percutaneous coronary intervention (PCI) with the Presillion™ CoCr bare metal stent will be randomized into three groups and administered (in a single dose intravenously (IV) through a peripheral venous catheter) either: low dose Liposomal Alendronate of 0.001 mg, high dose Liposomal Alendronate of 0.01 mg, or placebo (IV saline infusion) on a 1:1:1 basis.
All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up at 6 months.
All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up at 6 months.
Study Oversight
Has Oversight DMC:
False
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?: