Trial document





This trial has been registered retrospectively.
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  DRKS00015856

Trial Description

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Title

Endovascular Treatment of Patients with Critical Limb Ischemia

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Trial Acronym

GIKEI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Peripheral artery disease (PAD) is a major factor of morbidity and mortality in the western world. Endovascular Treatment Options and platelet Inhibition strategies are often necessary for the Management of PAD. The role of Fondaparinux as an adjunct Treatment Option will be evaluated within our study in this context.

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Brief Summary in Scientific Language

Lower extremity peripheral arterial disease (PAD) encompasses a wide range of vascular disorders caused by atherosclerotic or thromboembolic processes that alter the structure and function of the lower extremity peripheral arteries. (1) Symptomatic lower extremity PAD arises from inadequate blood flow, causing a mismatch between oxygen supply and demand.
Critical limb ischemia (CLI) is the most severe form of lower extremity PAD, which is defined as lower extremity pain, occurring at rest or in the presence of ulcers or gangrene, due to severely compromised tissue blood flow. (2) Recent data suggest that CLI may be more common than previously suggested. Thus, the recent Reduction of Atherothrombosis for Continued Health (REACH) registry showed that among patients with symptomatic PAD, up to 15% will experience major amputation. (3) Contemporary revascularization options of peripheral arterial disease encompass percutaneous transluminal angioplasty (PTA), drug-coated balloons, bare metal and drug-eluting stents as well as surgical options like distal bypass surgery and thromboendartectomy. (4) Particularly with critical limb ischemia, endovascular treatment represents the first line treatment option in most patients according to current guidelines. (5) In addition, smoking cessation, exercise and optimal medical therapy with statins, ACE inhibitors anti-platelet therapy as well as wound care are also essential for the successful treatment of CLI. (6) After revascularization by PTA and stent placement patients with CLI are usually treated with aspririn and clopidogrel for 2 months and are then continued on treatment with either aspirin or clopidogrel.
In this regard fondaparinux was previously shown to reduce cardiac mortality rates when administrated after coronary PCI and stent placement in patients with acute coronary syndromes. (7) Therefore, it is conceivable that patients with CLI would also profit from fondaparinux treatment after interventional revascularization in terms of 1. artery patency after PTA and stent placement, 2. Repeated revascularization procedures and 3. Minor and major amputation rates. The aim of the proposed study is to test this effect within an observational setting.

Current guidelines provided by the task force for the treatment of PAD recommend a ‘first endovascular’ approach when vascular revascularization is required in patients with CLI (8). Thus, such patients undergo PTA and if required stent placement in the compromised or occluded peripheral arteries.


Primary Objectives:
To investigate the ability of 2.5mg fondaparinux per day combined with aspirin and clopidogrel during the first 2 weeks after PTA with or without stent placement versus standard treatment with aspirin and clopidogrel (retrospective analysis), to improve the combined endpoint, consisting of
1. Reintervention
2. Restenosis
3. Major amputation at one year of follow-up.

Secondary Objectives:
Clinical improvement defined as cumulative improvement of 1 class by Fontaine scale, improved wound healing.

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Organizational Data

  •   DRKS00015856
  •   2018/11/12
  •   [---]*
  •   yes
  •   Approved
  •   S-100/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I70.25 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I70.22 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
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Interventions/Observational Groups

  •   To investigate the clinical parameters:

    1. Reintervention
    2. Restenosis
    3. Major amputation at one year of follow-up.

    in patients receiving 2.5mg fondaparinux per day or with other anticoagulants combined with aspirin and Clopidogrel during the first 2 weeks after PTA with or without stent placement.

    The Control Group ist treated by standard therapy.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

Primary Objectives:
To investigate the ability of 2.5mg fondaparinux per day combined with aspirin and clopidogrel during the first 2 weeks after PTA with or without stent placement versus standard treatment with aspirin and clopidogrel (retrospective analysis), to improve the combined endpoint, consisting of
1. Reintervention
2. Restenosis
3. Major amputation at one year of follow-up.

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Secondary Outcome

Secondary Objectives:
Clinical improvement defined as cumulative improvement of 1 class by Fontaine scale, improved wound healing.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/06/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Patients with PAD and critical limb ischemia.

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Exclusion Criteria

Exclusion criteria:
1. Fontaine Stages I or IIa without indication for endovascular treatment.
2. Acute limb-threatening ischemia of iliac and femoral arteries with indication for treatment with heparin, low-molecular heparins, new anticoagulants or cumadin.
3. Candidates requiring surgical revascularization or hybrid procedures after failed endovascular treatment
4. Severe renal failure, creatinine clearance <30 mL/min
5. Platelet count <100x109/L
6. Anemia with Hb<10.0 g/dL
7. History of or condition associated with increased bleeding risk including: trauma within 30 days before the index procedure, clinically significant gastrointestinal bleeding within the last 6 months, history of apoplexy within the last 3 months, fibrinolytics within 10 days before the index procedure, intracranial, intraocular, spinal, or atraumatic intra-articular bleeding, chronic hemorrhagic disorder, known intracranial neoplasm, arteriovenous malformation, or aneurysm, sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg, known significant liver disease (e.g., acute clinical hepatitis, liver cirrhosis)
8. Alcohol or drug abuse within 12 months before the index procedure.
9. Pregnancy, breast feeding or childbearing potential without proper contraceptive measures.
10. Indication for anticoagulation or dual platelet treatment due to atrial fibrillation, aortic valve replacement, vein thrombosis, acute coronary syndrome etc.
11. Unable to adhere to the study protocol.
12. Severe concomitant condition or disease (e.g. life expectancy <6 months, dementia or advanced liver disease).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GRN Klinik Weinheim
    • Mr.  Prof. Dr.  Grigorios  Korosoglou 
    • Röntgenstrasse 1
    • 69469  Weinheim
    • Germany
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    • GRN Klinik Weinheim
    • Mr.  Prof. Dr.  Grigorios  Korosoglou 
    • Röntgenstrasse 1
    • 69469  Weinheim
    • Germany
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  • start of 1:1-Block address scientific-contact
    • GRN Klinik Weinheim
    • Mr.  Prof. Dr.  Grigorios  Korosoglou 
    • Röntgenstrasse 1
    • 69469  Weinheim
    • Germany
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    • GRN Klinik Weinheim
    • Mr.  Prof. Dr.  Grigorios  Korosoglou 
    • Röntgenstrasse 1
    • 69469  Weinheim
    • Germany
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Sources of Monetary or Material Support

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    • Aspen Germany GmbH
    • Ms.  Dr.  Alexandra  Schimke 
    • Montgelaspark, Montgelasstraße 14
    • 81679  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/01
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.