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

NACompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

September 23, 2020

Primary Completion Date

June 16, 2023

Study Completion Date

June 16, 2023

Conditions
Acute Deep Vein Thrombosis
Interventions
DEVICE

Thrombolysis in combination with endhole aspiration

The treatment protocol the study team will be following is as follows. 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.

Trial Locations (1)

66160

University of Kansas Medical Center, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Penumbra Inc.

INDUSTRY

lead

University of Kansas Medical Center

OTHER

NCT04297787 - Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT | Biotech Hunter | Biotech Hunter