Inflow Improve for Deep Vein thrombOsis With Ultrasound acceLerated thrombOlysis and Venoplasty

Inflow Improve for Deep Vein thrombOsis With Ultrasound acceLerated thrombOlysis and Venoplasty: a Monocentric, Observational and Prospective Study.

Aim of the IDOLO study is to investigate clinical efficacy on ultrasound accelerated thrombolysis and venoplasty in patients with post-thrombotic syndrome secondary to chronical femoro-popliteal vein occlusion for previous deep vein Thrombosis (DVT).

At San Raffaele Hospital (Vascular Surgery Department) will be enrolled 50 patients with lower extremity deep vein thrombosis (who have failed conservative treatment) objectively diagnosed with imaging ≥ 6 months; prior persistent deep vein Thrombosis (DVT) at enrollment evaluation and moderate-severe post-thrombotic syndrome at time of procedure

Study Overview

• Status: Recruiting
• Conditions: Post-Thrombotic Syndrome of Both Legs
• Intervention / Treatment: Other: ultrasound accelerated thrombolysis and venoplasty

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Domenico Baccellieri, MD; Phone Number: 7377 +39022643; Email: baccellieri.domenico@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • Recruiting
    • San Raffaele Hospital
    • Contact: Domenico Baccellieri, MD; Phone Number: 7377 +39022643; Email: domenico.baccellieri@hsr.it
    • Contact: Elisa Simonini; Phone Number: 7141 +39022643; Email: simonini.elisa@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

At San Raffaele Hospital (Vascular Surgery Department) will be enrolled 50 patients with lower extremity deep vein thrombosis (who have failed conservative treatment) objectively diagnosed with imaging ≥ 6 months; prior persistent DVT at enrollment evaluation and moderate-severe post-thrombotic syndrome at time of procedure.

Description

Inclusion Criteria:

• Patient admitted in Vascular Surgery Unit, San Raffaele Hospital, Milan
• Patients able to sign specific informed consent for the study.
• Proximal deep vein Thrombosis (iliac vein, common femoral vein, deep femoral vein, and femoral vein) that was objectively diagnosed with duplex imaging and/or venography ≥ 6 months prior to study screening.
• Persistent chronic deep vein Thrombosis causing restrictive flow, as confirmed by imaging, within 60 days prior to the study procedure.
• Failed a minimum of 3 consecutive months of conservative treatment (therapeutic anticoagulation and compression stockings).
• Villalta score ≥8 for the affected limb within 30 days prior to the study procedure

Exclusion Criteria:

• Treated with mechanical thrombectomy within 2 weeks of the study thrombolysis procedure.
• Treated with thrombolysis drugs within 48 hours of the study thrombolytic procedure.
• Life expectancy less than (<) 1 year.
• Body Mass Index (BMI) greater than (>) 40 kilograms/square meter (kg/m^2) or per Investigator's discretion participant is able tolerate the procedure and be compliant with post-procedure increased physical activity.
• No flow in popliteal vein on duplex imaging
• Thrombus extending ≥ 3 centimeters (cm) into the inferior vena cava (IVC). If central venous occlusion, consider computed tomography (CT) or magnetic resonance venography (MRV). For participants with bilateral DVT, it is recommended that central imaging be performed prior to treatment to evaluate the status of the IVC.
• Active bleeding, recent (<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis.
• Recent (<3 months) internal eye surgery or hemorrhagic retinopathy; recent (<10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation (CPR), obstetrical delivery, or other invasive procedure.
• History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, or aneurysm.
• Active cancer (metastatic, progressive, or treated within the last 6 months). Participants with non-melanoma primary skin cancers are eligible to participate in the study.
• Hemoglobin <9.0 milligrams/deciliter (mg/dL) within 24 hours prior to the procedure
• International normalized ratio (INR) ≥1.5 nanograms/deciliter (ng/dL) within 24 hours prior to the procedure.
• Platelet count <100,000 cells/cubic millimeter (cells/mm^3) or >700,000 cells/mm^3 within 24 hours prior to the procedure.
• Creatinine outside the normal range for the treating institution and considered clinically significant by the Investigator.
• Uncontrolled hypertension, defined as systolic >175 millimeters of mercury (mmHg) and a diastolic >110 mmHg.
• Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug within 7 days of the study procedure.
• In the judgment of the clinician, the participant is at high risk for catastrophic bleeding.
• Impossibility or refusal to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DVT patients	Other: ultrasound accelerated thrombolysis and venoplasty; IDOLO Study investigate clinical efficacy on ultrasound accelerated thrombolysis and venoplasty in patients with post-thrombotic syndrome secondary to chronical femoro-popliteal vein occlusion for previous deep vein Thrombosis (DVT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Severity Scores	Improvement of Clinical efficacy will be evaluated using the Villalta score	up to 12 months
Major Bleeding	Freedom from Fatal bleeding, Symptomatic bleeding in a critical area or organ,Bleeding causing a fall in hemoglobin level of 20gL	72 hours

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Garcia MJ, Sterling KM, Kahn SR, Comerota AJ, Jaff MR, Ouriel K, Weinberg I; ACCESS PTS Investigators. Ultrasound-Accelerated Thrombolysis and Venoplasty for the Treatment of the Postthrombotic Syndrome: Results of the ACCESS PTS Study. J Am Heart Assoc. 2020 Feb 4;9(3):e013398. doi: 10.1161/JAHA.119.013398. Epub 2020 Jan 25.
• Grommes J, Strijkers R, Greiner A, Mahnken AH, Wittens CH. Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):526-32. doi: 10.1016/j.ejvs.2010.11.035. Epub 2011 Jan 21.
• Shi Y, Shi W, Chen L, Gu J. A systematic review of ultrasound-accelerated catheter-directed thrombolysis in the treatment of deep vein thrombosis. J Thromb Thrombolysis. 2018 Apr;45(3):440-451. doi: 10.1007/s11239-018-1629-y.
• Dumantepe M, Tarhan IA, Ozler A. Treatment of chronic deep vein thrombosis using ultrasound accelerated catheter-directed thrombolysis. Eur J Vasc Endovasc Surg. 2013 Sep;46(3):366-71. doi: 10.1016/j.ejvs.2013.05.019. Epub 2013 Jun 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: IDOLO Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No