NCT00163254

Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee

Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the adjunctive use of a GP IIb/IIIa 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 IIb/IIIa 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.

Conditions

• Patients Above 18 Years

Interventions

Type	Name	Description
DRUG	abciximab
DEVICE	stent and drug eluting stent

Timeline

• Start date: 2003-09-01
• Completion: 2006-11-01
• First posted: 2005-09-13
• Last updated: 2006-09-12

Locations

1 site across 1 country: Germany