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:
ThromboGenics
Information provided by:
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00123292
First received: July 21, 2005
Last updated: February 4, 2009
Last verified: November 2008
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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 |
| 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 More Information
No publications provided
| Responsible Party: | Geraldine Cahillane/ Director of Clinical Operations, ThromboGenics |
| ClinicalTrials.gov Identifier: | NCT00123292 History of Changes |
| Other Study ID Numbers: | TG-M-002 |
| Study First Received: | July 21, 2005 |
| Last Updated: | February 4, 2009 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines Belgium: Institutional Review Board |
Keywords provided by ThromboGenics:
|
arterial occlusion thromboembolism Acute Peripheral Arterial Occlusion |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013