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

This study has been terminated.
(Sponsor's decision not to pursue development of uPLi for vascular conditions)
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00123292
First received: July 21, 2005
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Arterial Occlusive Diseases
Drug: Microplasmin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: March 2005
Study Completion Date: November 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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).
Experimental: 2 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).
Experimental: 3 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).
Experimental: 4a 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).
Experimental: 4b 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123292

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, B-3000
Sponsors and Collaborators
ThromboGenics
Investigators
Principal Investigator: Peter Verhamme, MD, PhD KU Leuven
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00123292     History of Changes
Other Study ID Numbers: TG-M-002
Study First Received: July 21, 2005
Last Updated: April 4, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Institutional Review Board

Keywords provided by ThromboGenics:
arterial occlusion
thromboembolism
Acute Peripheral Arterial Occlusion

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014