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Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular litothripsy (IVL) | Device | endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | insertion/use of the device after crossing the steno-obstructive lesion and its removal without complications, restoration of vessel patency in the absence of stenosis/acute recoil >30%, rupture/perforation of the common femoral artery, need for a bailout stenting | Intraprocedural |
| Clinical success | absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure | Intraprocedural / 1 month |
| Primary patency | patency of the treated vessel in the absence of a restenosis >30% | 1 month / 6 months / 1 year |
| Primary assisted patency | patency of the treated vessel after one or more endovascular reinterventions | 1 month / 6 months / 1 year |
| Secondary patency | patency of the treated vessel after occlusione and treatment by surgical or endovascular means | 1 month / 6 months / 1 year |
| Clinically driven freedom from target lesion restenosis (cdTLR) | restenosis resulting in vessel occlusion or stenosis with maximum PSV > 2.5 m/sec | 1 month / 6 months / 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any reinterventions | 1 month / 6 months / 1 year | |
| Patency of profunda femoris | 1 month / 6 months / 1 year | |
| Limb salvage |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severely symptomatic peripheral arterial disease and concomitant atherosclerotic de novo lesions of the common femoral artery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Troisi, Prof | Contact | 00393280205530 | nicola.troisi@unipi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pisa | Recruiting | Pisa | 50012 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35595607 | Result | Baig M, Kwok M, Aldairi A, Imran HM, Khan MS, Moustafa A, Hyder ON, Saad M, Aronow HD, Soukas PA. Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up. Cardiovasc Revasc Med. 2022 Oct;43:80-84. doi: 10.1016/j.carrev.2022.05.003. Epub 2022 May 7. | |
| 34887206 |
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| 1 month / 6 months / 1 year |
| Wong CP, Chan LP, Au DM, Chan HWC, Chan YC. Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Mar;63(3):446-456. doi: 10.1016/j.ejvs.2021.10.035. Epub 2021 Dec 6. |
| 34167675 | Result | Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010. |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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