CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

Phase 3

Terminated

• Conditions: Lower Extremity Ischemia
• Interventions: Procedure: conventional embolectomy/thrombectomy; Procedure: embolectomy/thrombectomy with controlled reperfusion

• Registration Number: NCT00567801
• Lead Sponsor: University Hospital Freiburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-25
• Last Update Posted: 2008-07-28
• Primary Completion: 2009-09
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	conventional embolectomy/thrombectomy	conventional embolectomy/thrombectomy
2	embolectomy/thrombectomy with controlled reperfusion	embolectomy/thrombectomy with controlled reperfusion

Primary Outcome Measures

Name	Time	Method
Amputation-free survival	28 days

Secondary Outcome Measures

Name	Time	Method
Systemic complications in both therapy groups	4 weeks
Tolerance of reperfusion solution	4 weeks
Neurological status (motor function, sensor function) of ischemic limb	4 weeks
Lethality	12 months

Trial Locations

Locations (23)

University Medical Center Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Klinikum Lahr; 🇩🇪 Lahr, Baden-Württemberg, Germany

Klinikum Villingen-Schwenningen; 🇩🇪 Villingen-Schwenningen, Baden-Württemberg, Germany

St. Johanns-Spital Salzburg; 🇦🇹 Salzburg, Austria

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Herzzentrum Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Kiel; 🇩🇪 Kiel, Germany

St. Johannes-Hospital Dortmund; 🇩🇪 Dortmund, Germany

Kreisklinikum Donaueschingen; 🇩🇪 Donaueschingen, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Park-Krankenhaus Leipzig; 🇩🇪 Leipzig, Germany

Uniklinik Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Marienhospital Altenessen; 🇩🇪 Essen, Germany

St. Marien-Hospital Buer, Gelsenkirchen; 🇩🇪 Gelsenkirchen, Germany

Universitätsklinikum Giessen; 🇩🇪 Giessen, Germany

Universitätsklinikum Lübeck; 🇩🇪 Lübeck, Germany

Klinikum E. v. Bergmann Potsdam; 🇩🇪 Potsdam, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Städtisches Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Baden-Württemberg, Germany

Universitätsklinikum Mainz; 🇩🇪 Mainz, Germany

Universitätsklinikum Rostock; 🇩🇪 Rostock, Germany

Hegau-Klinikum Singen; 🇩🇪 Singen, Germany