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

Primary Purpose

Acute Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrombolysis in combination with endhole aspiration
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 4, 2020
Last Updated
June 16, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04297787
Brief Title
Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT
Acronym
INDIGO
Official Title
Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Penumbra Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Deep Vein Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Thrombolysis in combination with endhole aspiration
Intervention Description
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 Outcome Measure Information:
Title
Post-thrombotic Syndrome (PTS) severity using the Villalta score
Description
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).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Rohr, MD
Organizational Affiliation
Interventional Radiology-Vascular
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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