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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Hospital Tuebingen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00163254
First received: September 8, 2005
Last updated: September 11, 2006
Last verified: September 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00163254     History of Changes
Other Study ID Numbers: btk-1, D 30.08290
Study First Received: September 8, 2005
Last Updated: September 11, 2006
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

ClinicalTrials.gov processed this record on November 23, 2014