Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in … (NCT00163254) | Clinical Trial Compass
UnknownPhase 2
Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
GermanyStarted 2003-09
Plain-language 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.
Who can participate
Age range18 Years – 95 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 blee…
What they're measuring
1
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.