Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis

Summary

The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.

Conditions

• Deep Vein Thrombosis
• Venous Thrombosis
• Postphlebitic Syndrome
• Venous Thromboembolism
• Post Thrombotic Syndrome

Interventions

DRUG

Recombinant tissue plasminogen activator (rt-PA)

Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• Ontario Clinical Oncology Group (OCOG)

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• BSN Medical Inc

  collaborator INDUSTRY

• Genentech, Inc.

  collaborator INDUSTRY

• Medtronic - MITG

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• Mid America Heart Institute

  collaborator OTHER

• Society of Interventional Radiology Foundation

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Suresh Vedantham, M.D. · Clinical Coordinating Center at Washington University School of Medicine

• Clive Kearon, MB, MRCP, FRCP(C), PhD · Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group

• Samuel Z Goldhaber, M.D. · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• United States

Study Locations