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

NCT04297787 | Completed

• 1 other identifier: STUDY00145734
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

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

  Patient outcomes will be measured through clinical grading of PTS severity using the Villalta score, a clinical measure for the post-thrombotic syndrome that grades the severity, from 0 (absent) to 3 (severe), of each of 5 patient-rated symptoms (pain, cramps, heaviness, pruritus, and paresthesia) and 6 clinician-rated clinical signs (edema, redness, skin induration, hyperpigmentation, venous ectasia, and pain of calf). A summative score of 5 or more on the Villalta scale indicates the presence of the postthrombotic syndrome (Villalta).

  1 month

Study Arms (1)

Treatment

OTHER

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.

Device: Thrombolysis in combination with endhole aspiration

Interventions

Thrombolysis in combination with endhole aspiration DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Penumbra Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

• Aaron Rohr, MD

  Interventional Radiology-Vascular

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: September 23, 2020
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)