Status:
COMPLETED
A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Acute Peripheral Arterial Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasmino...
Eligibility Criteria
Inclusion
- Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa
- Onset of symptoms less than or equal to 14 days
- Thrombosed infrainguinal bypass graft or native artery
- Diagnosis by arteriography of occlusive thrombus in graft or artery
- Ability to embed the infusion catheter into the thrombus
- Women of childbearing potential must use contraception and have a negative pregnancy test
Exclusion
- Any medical or social condition that may interfere with study participation
- Women who are pregnant or lactating
- Hemorrhagic stroke history
- Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year
- Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months
- Major surgery, organ biopsy, or major trauma within the past 10 days
- Lumbar puncture or non-compressible arterial puncture in the past 10 days
- Intraocular surgery within the past 10 days
- Active gastrointestinal or organ bleeding
- Uncontrolled arterial hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
- Known intracranial neoplasm, aneurysm, or arteriovenous malformation
- Current bleeding diathesis
- Platelet count \<75 x 10e9/L
- Active graft infection
- Occlusion occurred within one month of synthetic graft placement
- Occlusion occurred within 6 months of autologous graft placement
- A sequential composite graft with dual outflows to correct multiple occlusions
- Medically unable to tolerate an open vascular procedure
- Known prothrombotic state
- Hemoglobin \<10.0 g/dL
- Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine \>2.0 mg/dL
- Treatment with a full dose plasminogen activator (PA) within the last 48 hours
- Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days
- Treatment with oral anticoagulants, and with an international normalized ratio of \>1.7
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01222117
Start Date
December 1 2010
End Date
January 1 2016
Last Update
January 16 2017
Active Locations (39)
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1
Kaleida Health System
Buffalo, New York, United States, 14209
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
3
Ziekenhuis Oost Limburg, Campus St. Jan
Genk, Limburg, Belgium, 3600
4
Erasme Hospital, Brussels
Brussels, Belgium, 1070