CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567801

Acronym

CRAIL

Enrollment

250

Registered

2007-12-05

Start date

2002-09-30

Completion date

2010-09-30

Last updated

2008-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Extremity Ischemia

Keywords

Lower Extremity, Ischemia

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.

Interventions

PROCEDUREconventional embolectomy/thrombectomy

PROCEDUREembolectomy/thrombectomy with controlled reperfusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Amputation-free survival	28 days

Secondary

Measure	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

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026