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Patients Above 18 YearsPhase 2NCT00163254

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

A Phase 2 study testing abciximab and stent and drug eluting stent in people with Patients Above 18 Years, run by University Hospital Tuebingen at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Patients Above 18 Years
What is being tested?
abciximab and stent and drug eluting stent
Type of treatment
Medical device
How many people
Not given
Where
1 siteGermany
Study dates
Sep 2003to Nov 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
abciximab, stent and drug eluting stent
Keywords
Chronic limb ischemia, Intervention, Restenosis, Patients above 18 years

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abciximabDrug

  • stent and drug eluting stentDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. The binary restenosis rate (restenosis > 50%) at 6 months

  2. The rate of mortality, amputation (including toes), repeat target vessel intervention, and healing of ulcers 2 and 6 months from randomization.

  3. Quality of life assessment 2 and at 6 months compared to baseline

  4. Change in ankle brachial index (ABI) after the intervention, at 2 and at 6 months.

  5. Change in Rutherford stages at 2 and at 6 months compared to baseline.

  6. Hospital days for index hospitalization

  7. Hospital days for repeat revascularization and amputation at 2 and 6 months

  8. Safety analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2005 (estimated)
  2. Study startSep 2003
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00163254
Sponsor's protocol ID
btk-1
Other IDs
D 30.08290
Status last verified
Sep 2006
First submitted
8 Sep 2005
Last updated
12 Sep 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abciximab and stent and drug eluting stent in people with Patients Above 18 Years, run by University Hospital Tuebingen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00163254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.

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