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

University Hospital Tuebingen1 site in 1 countrySeptember 2003

ConditionsPatients Above 18 Years

Drugsabciximab

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Patients Above 18 Years
Sponsor: University Hospital Tuebingen
Locations: 1
Primary Endpoint: The primary study objective is to demonstrate the superiority of an adjunctive administration of abciximab and drug eluting stents on the rate of subacute reocclusions at day 60 ± 10.
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

November 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital Tuebingen

Eligibility Criteria

Inclusion Criteria

•Patients with a history of peripheral artery disease with below the knee artery occlusion, or stenosis which mandates PTA or stent administration as first treatment modality. The history of peripheral artery occlusion has to at least 6 weeks, and the target vessel occlusion has to be no longer than 5 centimeters in length (corresponding to a maximum of 2 stents per treated lesion). The number of treated lesions per vessel in this study is limited to three. Only the major lesion will be allocated to one of the study groups, the other lesions will be treated by conventional PTA. A documentation of distal outflow (no occlusion until 3 cm above the upper joint ankle) is mandatory
•Severe stage of PAD with ulceration(s) corresponding to Rutherford stage 5 or 6.

Exclusion Criteria

•Acute limb ischemia
•Subacute ischemia with requires thrombolysis as first treatment modality
•Active bleeding or known bleeding diathesis
•Known severe hepatic or renal disorder (liver cirrhosis, stage B, C or serum creatinine \> 2.5 mg%)
•Hyperthyreosis
•Diabetes mellitus treated with metformin
•Known heparin induced thrombocytopenia (HIT, type 2)
•Major surgery, eye surgery or trauma within past 6 weeks
•History of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other CNS abnormality (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm), or history of aneurysm repair
•Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks

Outcomes

Primary Outcomes

The primary study objective is to demonstrate the superiority of an adjunctive administration of abciximab and drug eluting stents on the rate of subacute reocclusions at day 60 ± 10.

Secondary Outcomes

The binary restenosis rate (restenosis > 50%) at 6 months
The rate of mortality, amputation (including toes), repeat target vessel intervention, and healing of ulcers 2 and 6 months from randomization.
Quality of life assessment 2 and at 6 months compared to baseline
Change in ankle brachial index (ABI) after the intervention, at 2 and at 6 months.
Change in Rutherford stages at 2 and at 6 months compared to baseline.
Hospital days for index hospitalization
Hospital days for repeat revascularization and amputation at 2 and 6 months
Safety analysis