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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Arterial Occlusive Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Microplasmin

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

Microplasmin

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No