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

University of Kansas

Status: Completed

Conditions: Acute Deep Vein Thrombosis

Treatments: Device: Thrombolysis in combination with endhole aspiration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04297787

STUDY00145734

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and efficacy of thrombolysis in combination with endhole aspiration in the treatment of acute deep vein thrombosis (DVT). Secondarily, the study team hope to illuminate the financial implications of single session catheter directed therapy versus a potential 48 hour lysis procedure (Lysis is an approach in which vascular specialists deliver clot-dissolving drugs directly to the site of the clot through a catheter).

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years of age
• Onset of acute DVT occurred <14 days
• Ability to undergo thrombolysis in combination with Indigo endhole aspiration device

Exclusion criteria

• Under 18 years of age
• Presence of subacute (14-28 days) or chronic DVT (>28 days)
• Contraindication to mechanical thrombectomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Treatment

Other group

Description:

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:

Device: Thrombolysis in combination with endhole aspiration