Actively Recruiting
Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty
Led by IRCCS San Raffaele · Updated on 2025-03-24
50
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient admitted in Vascular Surgery Unit, San Raffaele Hospital, Milan
- Able to sign specific informed consent for the study
- Proximal deep vein thrombosis (iliac vein, common femoral vein, deep femoral vein, and femoral vein) objectively diagnosed by duplex imaging and/or venography at least 6 months before screening
- Persistent chronic deep vein thrombosis causing restrictive flow confirmed by imaging within 60 days prior to procedure
- Failed minimum 3 consecutive months of conservative treatment including therapeutic anticoagulation and compression stockings
- Villalta score of 8 or higher for the affected limb within 30 days prior to procedure
You will not qualify if you...
- Treated with mechanical thrombectomy within 2 weeks before thrombolysis procedure
- Treated with thrombolysis drugs within 48 hours before thrombolytic procedure
- Life expectancy less than 1 year
- Body Mass Index greater than 40 kg/m2 or unable to tolerate procedure and post-procedure physical activity
- No flow in popliteal vein on duplex imaging
- Thrombus extending 3 cm or more into the inferior vena cava
- Active bleeding or recent gastrointestinal bleeding within last 3 months
- Active peptic ulcer, severe liver dysfunction, or bleeding diathesis
- Recent internal eye surgery or hemorrhagic retinopathy within 3 months
- Recent major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or invasive procedure within specified time frames
- History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, or aneurysm
- Active cancer (metastatic, progressive, or treated within last 6 months) except non-melanoma primary skin cancers
- Hemoglobin less than 9.0 mg/dL within 24 hours before procedure
- International normalized ratio (INR) 1.5 or higher within 24 hours before procedure
- Platelet count less than 100,000 or greater than 700,000 cells/mm3 within 24 hours before procedure
- Creatinine outside normal range and clinically significant
- Uncontrolled hypertension with systolic over 175 mmHg or diastolic over 110 mmHg
- Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drugs within 7 days before procedure
- High risk for catastrophic bleeding as judged by clinician
- Unable or unwilling to give informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
D
Domenico Baccellieri, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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