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

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00163254

Purpose

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.

Condition	Intervention	Phase
Patients Above 18 Years	Drug: abciximab Device: stent and drug eluting stent	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee

Resource links provided by NLM:

Drug Information available for: Abciximab

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

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 Outcome Measures:

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

Study Start Date:	September 2003
Estimated Study Completion Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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
Severe uncontrolled hypertension (treated sys. BP > 200 mm Hg, diast. BP > 100 mm Hg)
Known autoimmune disorders
Patient with vasculitis
Patient with aspirin intolerance
Contraindication or known allergic reactions to rapamycin, abciximab or murine proteins
Co-existent condition associated with a limited life expectancy (e.g., advanced cancer, end-stage congestive heart failure)
Women of child-bearing potential with a positive pregnancy test
Patient in prison or any vulnerable patient (soldier,…) as defined in the declaration of Helsinki

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163254

Locations

Germany
University of Tuebingen
Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Gunnar Tepe, MD

University Hospital Tuebingen

More Information

No publications provided

Study ID Numbers:	btk-1, D 30.08290
Study First Received:	September 8, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00163254 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

Chronic limb ischemia
Intervention
Restenosis
Patients above 18 years

Study placed in the following topic categories:

Abciximab
Ischemia

ClinicalTrials.gov processed this record on September 11, 2009