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

PHASE2TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

June 30, 2007

Study Completion Date

November 30, 2009

Conditions
Arterial Occlusive Diseases
Interventions
DRUG

Microplasmin

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).

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).

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.

Trial Locations (1)

B-3000

University Hospital Gasthuisberg, Leuven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ThromboGenics

INDUSTRY

NCT00123292 - Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion | Biotech Hunter | Biotech Hunter