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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00123292
• Date of registration: 21/07/2005
• Prospective Registration: No
• Primary sponsor: ThromboGenics
• Public title: Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
• Scientific title: An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
• Date of first enrolment: March 2005
• Target sample size: 19
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00123292
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Peter Verhamme, MD, PhD
• Affiliation: KU Leuven

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arterial Occlusive Diseases

Intervention(s)

Drug: Microplasmin

Primary Outcome(s)

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 Outcome(s)

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).]

Secondary ID(s)

TG-M-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors