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

Acute Deep Vein Thrombosis Clinical Trial

— INDIGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297787
• Other study ID #: STUDY00145734
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: June 16, 2023

Study information

• Verified date: June 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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