Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty: a Monocentric, Observational and Prospective Study.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Domenico Baccellieri, MD
baccellieri.domenico@hsr.it
+39022643
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 50
Treatments
DVT patients
Sponsors
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov