Razavi et al., JVIR 2021.
Background
Catheter directed thrombolytics (CDT) often require prolonged exposure to thrombolytic agents which can increase bleed risk. CDT typically requires inpatient care making the treatment inappropriate for outpatient settings.
Objective
To investigate the short-term results of single-session treatment of iliocaval and iliofemoral venous thrombosis using the JETi™ Peripheral Thrombectomy System and evaluate potential for treatment on an outpatient basis.
Methods
Prospective pilot study of 47 patients (53 limbs) who presented with symptomatic iliocaval or iliofemoral venous thromboembolism and subsequently underwent percutaneous mechanical thrombectomy with the intention to treat in a single-session. Obstructive lesions were treated with adjunctive therapy, including balloon angioplasty and stenting, as needed.
Endpoints
Reestablishment of unobstructed flow in a single-session, freedom from major adverse events (MAE), improvement in the clot burden utilizing the VRI scoring system and device-related adverse events.
Overall, single-session unobstructed flow was reestablished in 89% of limbs with no major adverse events through 30 days. Including patients requiring requiring catheter directed thrombolytics (CDT), restoration of flow was successfully achieved in 94% of treated segments.
| Segment | Flow Restoration: JETi™ Alone | Flow Restoration: JETi™ + Stent* |
|---|---|---|
| Iliocaval | 86% (12/14) | 100% (14/14) |
| Iliofemoral | 75% (27/36) | 92% (33/36) |
| Femoropopliteal | 100% (3/3) | N/A |
*Data includes patients who underwent overnight CDT.
Unobstructed flow was re-established in 89% of limbs in a single-session.
Single-session treatment with the JETi™ thrombectomy device may reduce the risk of bleeding when compared with CDT and eliminate the need for overnight admission in the majority of cases.
Restoration of flow was achieved in 94% of treated segments.
Razavi et al., JVIR. 2021.
MAT-2209357 v1.0
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MAT-2305078 v1.0
