Post-Thrombotic Syndrome of Both LegsNCT06198816
Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty
An observational study of Post-Thrombotic Syndrome of Both Legs, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Thrombotic Syndrome of Both Legs
- What is being tested?
- ultrasound accelerated thrombolysis and venoplasty
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jan 2024to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital
Milan, Italy, 20132
Domenico Baccellieri, MD, +39022643 ext. 7377, domenico.baccellieri@hsr.it
Elisa Simonini, +39022643 ext. 7141, simonini.elisa@hsr.it
About this study
Official title: 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
- Conditions
- Post-Thrombotic Syndrome of Both Legs
- Being tested
- ultrasound accelerated thrombolysis and venoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound accelerated thrombolysis and venoplastyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| DVT patients | Not described Receives: Other: ultrasound accelerated thrombolysis and venoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Severity Scores
Improvement of Clinical efficacy will be evaluated using the Villalta score
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start29 Jan 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-Thrombotic Syndrome of Both LegsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baccellieri Domenico, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198816
- Sponsor's protocol ID
- IDOLO Study
- Status last verified
- Mar 2025
- First submitted
- 28 Dec 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31983322Grommes 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.
PubMed 21256773Shi 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.
PubMed 29417407Dumantepe 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.
PubMed 23806796
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty: a Monocentric, Observational and Prospective Study.
- ClinicalTrials.gov ID
- NCT06198816
- Acronym / sponsor ID
- IDOLO Study
- Conditions
- Post-Thrombotic Syndrome of Both Legs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DVT patients | – | Other: ultrasound accelerated thrombolysis and venoplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound accelerated thrombolysis and venoplastyIDOLO 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). | Other | DVT patients |
Primary outcome
Clinical Severity Scores
Time frame: up to 12 months
Improvement of Clinical efficacy will be evaluated using the Villalta score
Major Bleeding
Time frame: 72 hours
Freedom from Fatal bleeding, Symptomatic bleeding in a critical area or organ,Bleeding causing a fall in hemoglobin level of 20gL
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 31983322Garcia 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.
- Background: PubMed 21256773Grommes 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.
- Background: PubMed 29417407Shi 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.
- Background: PubMed 23806796Dumantepe 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Thrombotic Syndrome of Both Legs, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico Baccellieri, MD (+39022643 ext. 7377, baccellieri.domenico@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Severity Scores (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198816, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.