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Completed

NCT Number: NCT04297787

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

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).

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Key information

Conditions

Acute Deep Vein Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 month

    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).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Penumbra Inc.

Registry information

Official study title

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

Acronym: INDIGO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2020
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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