An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Overview
- Phase
- Phase 2
- Intervention
- Microplasmin
- Conditions
- Arterial Occlusive Diseases
- Sponsor
- ThromboGenics
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
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.
Arms & Interventions
1
Intervention: Microplasmin
2
Intervention: Microplasmin
3
Intervention: Microplasmin
4a
Intervention: Microplasmin
4b
Intervention: Microplasmin
Outcomes
Primary Outcomes
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 Outcomes
- Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)(At 4 hours or less (if study drug administration is terminated prior to 4 hours).)