CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

University Hospital Freiburg

Status and phase

Terminated

Phase 3

Conditions

Lower Extremity Ischemia

Treatments

Procedure: conventional embolectomy/thrombectomy

Procedure: embolectomy/thrombectomy with controlled reperfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00567801

S 991228

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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