NCT00418483

Brief Summary

The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

January 2, 2007

Last Update Submit

October 28, 2016

Conditions

Arterial Occlusive Diseases

Keywords

thrombolyticthrombolysisacute peripheral arterial occlusionperipheral vascular diseasethrombosisendovascular

Outcome Measures

Primary Outcomes (1)

  • Thrombolysis

    Thrombolysis at the end of treatment compared to baseline by arteriography

    Approximately 5 hours after start of treatment

Secondary Outcomes (7)

  • Thrombolysis

    Approximately 2 hours after start of treatment

  • Avoidance of open surgical procedures

    30 days

  • Avoidance of amputation

    30 days

  • Avoidance of additional catheter-directed thrombolysis with a plasminogen activator or mechanical device thrombectomy

    30 days

  • Avoidance of both open surgical procedures and additional thrombolysis with a plasminogen activator or mechanical device thrombectomy.

    30 days

  • +2 more secondary outcomes

Study Arms (7)

Plasmin (Human) 25 mg

EXPERIMENTAL

Plasmin (Human) 25 mg

Biological: Plasmin (Human) 25 mg

Plasmin (Human) 50 mg

EXPERIMENTAL

Plasmin (Human ) 50 mg

Biological: Plasmin (Human) 50 mg

Plasmin (Human) 75 mg

EXPERIMENTAL

Plasmin (Human) 75 mg

Biological: Plasmin (Human) 75 mg

Plasmin (Human) 100 mg

EXPERIMENTAL

Plasmin (Human) 100 mg

Biological: Plasmin (Human) 100 mg

Plasmin (Human) 125 mg

EXPERIMENTAL

Plasmin (Human) 125 mg

Biological: Plasmin (Human) 125 mg

Plasmin (Human) 150 mg

EXPERIMENTAL

Plasmin (Human) 150 mg

Biological: Plasmin (Human) 150 mg

Plasmin (Human) 175 mg

EXPERIMENTAL

Plasmin (Human) 175 mg

Biological: Plasmin (Human) 175 mg

Interventions

Plasmin (Human) 25 mgBIOLOGICAL

Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 25 mg
Plasmin (Human) 50 mgBIOLOGICAL

Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 50 mg
Plasmin (Human) 75 mgBIOLOGICAL

Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 75 mg
Plasmin (Human) 100 mgBIOLOGICAL

Plasmin (Human) 100 mg

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 100 mg
Plasmin (Human) 125 mgBIOLOGICAL

Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 125 mg
Plasmin (Human) 150 mgBIOLOGICAL

Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 150 mg
Plasmin (Human) 175 mgBIOLOGICAL

Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Also known as: TAL-05-00018, BAY-57-9602
Plasmin (Human) 175 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry.
  • Unilateral limb ischemia: SVS acute ischemia Category I or IIa.
  • Onset of symptoms \</= 14 days.
  • Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, only occlusions of ≥ 10 cm in length are eligible.
  • Diagnosis of occlusive thrombus in the graft or artery by arteriography after Informed Consent is obtained.
  • Ability to traverse the thrombus with a guidewire.
  • Signed informed consent prior to study entry.

You may not qualify if:

  • Clinical evidence of significant disease that may interfere with the patient successfully completing the trial.
  • Women who are pregnant or lactating, or first 10 days post-partum.
  • Previous hemorrhagic stroke at any time. Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack (TIA)) within one year.
  • Intracranial or spinal neuro-surgery, or severe intracranial trauma in the last 3 months. Major surgery, organ biopsy, or major trauma within the last 10 days. Lumbar puncture or non-compressible arterial puncture in the last 10 days. Intra-ocular surgery within the last 10 days.
  • Uncontrolled arterial hypertension, defined as a systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg.
  • Known intracranial neoplasm, aneurysm, or arterio-venous malformation.
  • Platelet count \< 75 x 10e9/L.
  • Occlusion of a graft within 6 months of placement.
  • Medically unable to tolerate an open vascular procedure.
  • Known prothrombotic condition.
  • Hemoglobin \<10.0 g/dL
  • Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine \> 2.0 mg/dL or subjects on renal dialysis.
  • Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days, for example, abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban (Aggrastat®).
  • Treatment with warfarin (Coumadin®) and with an INR of \>1.7 (elevated INR at screening may be corrected prior to study enrollment.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesPeripheral Vascular DiseasesThrombosis

Interventions

Fibrinolysin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

Study Officials

  • Anthony J Comerota, MD

    Jobst Vascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

US(1)