Back to resultsIntra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Primary Purpose
Arterial Occlusive Diseases
Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Microplasmin
Microplasmin
Microplasmin
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring arterial occlusion, thromboembolism, Acute Peripheral Arterial Occlusion
Eligibility Criteria
Inclusion Criteria: Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft). Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography. Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b). Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception). Exclusion Criteria: Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III). Occlusion not penetrable by the infusion guide wire. Known or suspected allergy to contrast agents or heparin sodium. Active bleeding or known hemorrhagic diathesis. Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
Sites / Locations
- University Hospital Gasthuisberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4a
4b
Arm Description
Outcomes
Primary Outcome Measures
Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
Secondary Outcome Measures
Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00123292
Brief Title
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Official Title
An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision not to pursue development of uPLi for vascular conditions
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.
Detailed Description
This clinical trial is designed as an open-label, dose-escalating, single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with acute peripheral arterial occlusion. Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours. Different dose regimens will be evaluated in an ascending-dose fashion; an infusion will be administered for up to 4 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases
Keywords
arterial occlusion, thromboembolism, Acute Peripheral Arterial Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4a
Arm Type
Experimental
Arm Title
4b
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Microplasmin
Intervention Description
An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
Intervention Type
Drug
Intervention Name(s)
Microplasmin
Intervention Description
An infusion of 0.45 mg/kg/hr in conjunction with distal protection device will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
Intervention Type
Drug
Intervention Name(s)
Microplasmin
Intervention Description
An infusion of 20 or 40 mg (20 mg for the 15 cm treatment length device; 40 mg for the 30 cm treatment length device) over 10 minutes via the Trellis-8 Peripheral Infusion System catheter, in accordance with the Trellis-8 Instructions for Use. For occlusive lesions that are longer than the treatment length of the Trellis-8 device, a repeat infusion of the same dose and duration may be administered.
Primary Outcome Measure Information:
Title
Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
Time Frame
at 4 hours or less (if study drug administration is terminated prior to 4 hours).
Secondary Outcome Measure Information:
Title
Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)
Time Frame
At 4 hours or less (if study drug administration is terminated prior to 4 hours).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).
Exclusion Criteria:
Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
Occlusion not penetrable by the infusion guide wire.
Known or suspected allergy to contrast agents or heparin sodium.
Active bleeding or known hemorrhagic diathesis.
Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Verhamme, MD, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
12. IPD Sharing Statement
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Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
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