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Thrombolytic Agent
Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
Phase 4
Waitlist Available
Led By Ehab A Eltahawy, MD
Research Sponsored by University of Toledo Health Science Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-24 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether a treatment involving a catheter and thrombolysis (using tPA) can help reduce post-thrombotic syndrome for people who have had deep vein thrombosis.
Eligible Conditions
- Post Thrombotic Syndrome
- Deep Vein Thrombosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-thrombotic syndrome at any time between 6-month and 24-month.
Secondary study objectives
Degree of Resolution of Thrombus with PCDT at 12 months.
Degree of Resolution of Thrombus with PCDT at 18 months.
Degree of Resolution of Thrombus with PCDT at 24 months.
+23 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacomechanical thrombolysis plus anticoagulationExperimental Treatment1 Intervention
This group of patients will receive Pharmacomechanical catheter-directed thrombolysis (PCDT) plus Anticoagulation.
PCDT will be AngioJet along with alteplase. Anticoagulation will be heparin only
Group II: AnticoagulationActive Control1 Intervention
This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only
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Who is running the clinical trial?
University of Toledo Health Science CampusLead Sponsor
41 Previous Clinical Trials
16,404 Total Patients Enrolled
Ehab A Eltahawy, MDPrincipal InvestigatorUniversity of Toledo Health Science Campus