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

Phase 2TerminatedNCT00123292

ThromboGenics19 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arterial Occlusive Diseases

Interventions

MicroplasminDRUG

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).

MicroplasminDRUG

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).

MicroplasminDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Gasthuisberg

Leuven, Belgium

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)

Time frame: At 4 hours or less (if study drug administration is terminated prior to 4 hours).

Data from ClinicalTrials.gov

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