Intravenous versus catheter directed thrombolytic therapy in non-traumatic acute limb ischemia

Phase 2

• Conditions: Obliteration of lower extremity arteries.; Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere

• Registration Number: IRCT2014100719427N1
• Lead Sponsor: Vice chancellor of Research, Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Age 18 to 75 years; symptoms duration of 1 to 14 days; Acute limb ischemia (ALI) of grade IIa and IIb according to the Rutherford classification; absence of distal run off in angiography; Ankle-Brachial Index (ABI) less than 0.8

Exclusion criteria: Severe anemia (Hb less than 8 gr per dL); thrombocytopenia (platelet count less than 80000 per micl); low serum fibrinogen (fibrinogen less than 100 mg per dL); severe hypertension (systolic more than 160 mmHg, diastolic more than 100 mmHg); trauma or surgery less than 14 days before intervention; history of subarachnoid hemorrhage; life expectancy of less than 14 months; major internal bleeding less than 6 months before intervention; pregnancy; lumbar puncture 2 weeks before intervention

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical condition. Timepoint: 1 week, 1, 3, 6, 12 months. Method of measurement: Rutherford classification; Pain severity measured by VAS; ABI.

Secondary Outcome Measures

Name	Time	Method
Complete or near complete recanalization of the occluded artery. Timepoint: 12 months. Method of measurement: Angiography.