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

NCT00163254 | Unknown Phase 2

• 2 other identifiers: btk-1D 30.08290
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Above 18 Years

Keywords

Chronic limb ischemia; Intervention; Restenosis; Patients above 18 years

Outcome Measures

Primary Outcomes (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.

Secondary Outcomes (8)

• 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.

Interventions

abciximab DRUG

stent and drug eluting stent DEVICE

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Puncture of a non compressible vessel within past 24 hours
• Administration of oral anticoagulants within the previous 7 days unless prothrombin time is \< 1.2 times control (or international normalized ratio \[INR\] \<1.4), or ongoing treatment with oral anticoagulants
• History of bleeding diathesis of platelet count \< 100,000/mm3
• Known ReoPro-induced thrombocytopenia
• Arteriovenous malformations or aneurysms

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Abciximab; Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Gunnar Tepe, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: September 1, 2003
• Study Completion: November 1, 2006
• Last Updated: September 12, 2006

Record last verified: 2006-09

Locations

DE (1)