Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053716
Status:
UNKNOWN
Last Update Posted:
2007-03-07
First Post:
2003-02-04
Brief Title:
Prostaglandin E1 Liprostin Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
Sponsor:
Endovasc
Organization:
Endovasc
Study Overview
Official Title:
Phase II Single Center Non-Controlled Open-Label Study of Liposomal Prostaglandin E1 Liprostin as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease
Status:
UNKNOWN
Status Verified Date:
2004-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the first clinical research trial in which intravenous Prostaglandin E1 PGE1 is a vasoactive hormone will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease
Detailed Description:
PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include pain at rest a numbing sensation in limb or feet limited ability to walk before pain occurs PAOD can occur along with diabetic ulcers
Proposed treatment will be given at a medical center with an overnight hospital stay Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug Liprostin a special formulation of liposomal Prostaglandin E1or PGE1 a natural occuring vasoactive hormone Drug treatment is given twice to each artery to be treated just before and after angioplasty When angioplasty procedure is completed a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure
A total of 12 PAOD subjects will be enrolled in a single center Memorial Hermann Hospital Houston TX
Study will begin in February 2003 with the last 12th subject to be enrolled likely by August 20
Proposed treatment will be given at a medical center with an overnight hospital stay Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug Liprostin a special formulation of liposomal Prostaglandin E1or PGE1 a natural occuring vasoactive hormone Drug treatment is given twice to each artery to be treated just before and after angioplasty When angioplasty procedure is completed a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure
A total of 12 PAOD subjects will be enrolled in a single center Memorial Hermann Hospital Houston TX
Study will begin in February 2003 with the last 12th subject to be enrolled likely by August 20
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Limb Arterial Disease Study | None | None | None |