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Thrombolytic Agent

Treatment for Deep Vein Thrombosis (INDIGO Trial)

N/A

Waitlist Available

Led By Aaron Rohr, MD

Research Sponsored by University of Kansas Medical Center

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 1 month

Awards & highlights

INDIGO Trial Summary

This trial is testing a new way to dissolve clots in people with DVT. They will compare it to the current standard of care and also look at the financial implications.

Eligible Conditions

Deep Vein Thrombosis (DVT)

INDIGO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-thrombotic Syndrome (PTS) severity using the Villalta score

INDIGO Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

The treatment protocol the study team will be following is as follows for all enrolled patients. First, a pulse spray tPA infusion with 20 cc of 8 mg tPA and saline will be administered to the thrombus with a 20-minute dwell time. Afterwards, an 8F curved sheath (Indigo 8 Torq Tip, ranges 85 to 115 cm) with CAT8 penumbra device will be used to aspirate the thrombus. If the operating physician deems necessary, they will have the option at that point to balloon plasty, stent, or use catheter-directed thrombolysis at this point. Clinical parameters such as areas of clinically-significant stenosis, extent of thrombus, (more parameters) will be tracked at the time of the procedure. The device is being used is FDA approved and being used according to FDA indications.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thrombolysis in combination with endhole aspiration

2020

N/A

~10

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

461 Previous Clinical Trials

169,154 Total Patients Enrolled

Penumbra Inc.Industry Sponsor

35 Previous Clinical Trials

9,107 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

290 Patients Enrolled for Deep Vein Thrombosis

Aaron Rohr, MDPrincipal InvestigatorInterventional Radiology-Vascular

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are participating in the clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this research endeavour, initially posted on September 23rd 2020, is presently recruiting individuals to take part in it. 30 patients need to be recruited from one site for the trial's completion."

Answered by AI

Is there still capacity for participants in this research project?

"Affirmative. Clinicaltrials.gov verifies that this research initiative, which opened on September 23rd 2020, is currently recruiting patients. 30 participants are necessary and they will be sourced from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT

2020. "Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04297787.