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

Arterial Occlusive Diseases Clinical Trial

Official title:

An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00123292
• Other study ID #: TG-M-002
• Status: Terminated
• Phase: Phase 2
• First received: July 21, 2005
• Last updated: April 4, 2014
• Start date: March 2005
• Est. completion date: November 2009

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

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).
• 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).
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)		at 4 hours or less (if study drug administration is terminated prior to 4 hours).	No
Secondary	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).	No