Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty

San Donato Group (GSD)

Status: Enrolling

Conditions: Post-Thrombotic Syndrome of Both Legs

Treatments: Other: ultrasound accelerated thrombolysis and venoplasty

Study type: Observational

Funder types: Other

Identifiers

NCT06198816

IDOLO Study

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

DVT patients

Treatment:

Other: ultrasound accelerated thrombolysis and venoplasty