Endovascular Treatment of Patients with Critical Limb Ischemia

• Conditions: I70.25; I70.22

• Registration Number: DRKS00015856
• Lead Sponsor: GRN Klinik Weinheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-10-01
• Study Start: 2018-11-12
• Results First Posted: 2020-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with PAD and critical limb ischemia.

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).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objectives:<br>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 <br>1. Reintervention<br>2. Restenosis <br>3. Major amputation at one year of follow-up.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives:<br>Clinical improvement defined as cumulative improvement of 1 class by Fontaine scale, improved wound healing.<br>