CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

Study Overview
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Brief Summary
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The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.

Official Title
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Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)

Conditions
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Lower Extremity Ischemia

Intervention / Treatment
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* Procedure: conventional embolectomy/thrombectomy
* Procedure: embolectomy/thrombectomy with controlled reperfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III) Informed consent of the patient Exclusion Criteria: Previous attempt of recanalisation (e.g. lysis therapy) Known A. poplitea aneurysm of the affected extremity Severe heart failure NYHA IV Known atrial thrombus Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy, previous transplantation of kidney) Hypersensitivity to allopurinol Hypersensitivity to one component part of the reperfusion solution Participation in a clinical trial during the study or 30 days before Pregnancy or lactation Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial Abuse to drugs or alcohol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>conventional embolectomy/thrombectomy | Procedure: conventional embolectomy/thrombectomy<br> <br> |
| Experimental: 2<br>embolectomy/thrombectomy with controlled reperfusion | Procedure: embolectomy/thrombectomy with controlled reperfusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation-free survival |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological status (motor function, sensor function) of ischemic limb |  | 4 weeks | 
| Systemic complications in both therapy groups |  | 4 weeks | 
| Tolerance of reperfusion solution |  | 4 weeks | 
| Lethality |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Extremity, Ischemia