Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163254
Status:
UNKNOWN
Last Update Posted:
2006-09-12
First Post:
2005-09-08
Brief Title:
Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
The Below-Study is a randomized prospective mono-centre trial on the efficacy and safety the adjunctive use of a GP IIbIIIa antagonist for prevention of early reocclusion in arterial below-the knee interventions
Detailed Description:
PTA below the knee is limited due to subacute reocclusions and uncertain long-term results This study is designed as a feasibility trial which compares the two new treatment modalities drug eluting stents and GP IIbIIIa blockade
Patients with current ulcers Rutherford 5 or 6 are randomly assigned to one of the treatment groups 1 ReoPro Sirolimus coated stent 2 ReoPro bare Stent 3 ReoPro PTA 4 PTA without ReoPro Angiographic control will be at 2 and 6 months with block wise randomisation to the treatment groups
Patients with current ulcers Rutherford 5 or 6 are randomly assigned to one of the treatment groups 1 ReoPro Sirolimus coated stent 2 ReoPro bare Stent 3 ReoPro PTA 4 PTA without ReoPro Angiographic control will be at 2 and 6 months with block wise randomisation to the treatment groups
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 |
|---|---|---|---|
| D 3008290 | None | None | None |