Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVT patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound accelerated thrombolysis and venoplasty | Other | 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). |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico Baccellieri, MD | Contact | +39022643 | 7377 | baccellieri.domenico@hsr.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Recruiting | Milan | Italy | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31983322 | Background | 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. | |
| 21256773 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 29417407 | Background | 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. |
| 23806796 | Background | 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. |