Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

ThromboGenics

Status and phase: Terminated; Phase 2

Conditions: Arterial Occlusive Diseases

Treatments: Drug: Microplasmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00123292

TG-M-002

Details and patient eligibility

About

The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 5 patient groups

1

Experimental group

Treatment:

Drug: Microplasmin

Drug: Microplasmin

Drug: Microplasmin

2

Experimental group

Treatment:

Drug: Microplasmin

Drug: Microplasmin

Drug: Microplasmin

3

Experimental group

Treatment:

Drug: Microplasmin

Drug: Microplasmin

Drug: Microplasmin

4a

Experimental group

Treatment:

Drug: Microplasmin

Drug: Microplasmin

Drug: Microplasmin

4b

Experimental group

Treatment:

Drug: Microplasmin

Drug: Microplasmin

Drug: Microplasmin