A Phase 3, Multicenter, Multi-national, Randomized, Double-Blind, Placebo-Controlled study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects with Acute Peripheral Arterial Occlusion (NAPA-3). - NAPA-3

Phase 1

• Conditions: Acute Peripheral Arterial Occlusion (acute PAO) is to peripheral vascular disease what acute coronary syndromes are to atherosclerotic heart disease and what stroke is to atherosclerotic cerebrovascular diease. Leg attack, heart attack, and brain attack alike, require prompt restoration of arterial blood flow in order to affect a minimization of symptoms, tissue damage, morbidity, and mortality.

• Registration Number: EUCTR2005-004901-27-NL
• Lead Sponsor: uvelo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-22
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

a) The subject (or legally acceptable representative) must give written informed consent
b) Age 18 years or older
c) Arteriographically confirmed acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization
d) Acute index limb ischemia classified as SVS/ISCVS Class I or IIA caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). Only Class I subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible.
e) Acute PAO with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy
f) Available for follow-up assessments

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) Contraindication to systemic anticoagulation e.g., history of documented hemorrhage requiring treatment within the past 30 days; history of a hereditary bleeding disorder or known bleeding diathesis, major surgery or trauma, open chest massage, ocular surgery or hemorrhagic retinopathy within the past 30 days; puncture at non-compressible site within 48 hours prior to administration of study drug; and history of stroke, intracranial hemorrhage, or central nervous system structural abnormalities within the past 3 months
b) History of endovascular procedure or open vascular surgery on the index limb within the last 30 days
c) History of significant acute or chronic kidney disease that would preclude contrast angiography
d) Known allergy to contrast agents
e) History of heparin-induced thrombocytopenia (HIT)
f) Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
g) Any thrombolytic therapy within 5 days prior to randomization
h) Past participation in any alfimeprase clinical trial
i) Pregnant, lactating, or actively menstruating women and women o child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
j) Investigator inability to advance guidewire through index occlusion
k) Any other subject feature that in the opinion of the investigator should preclude study participation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified