3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions

Study Overview
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Brief Summary
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The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between December 1, 2016 and December 31, 2020 at the Clinique Rhône-Durance, Avignon, France

Detailed Description
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This study is a non-interventional, retrospective, descriptive, single-centre study of adult male and female patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions, in order to assess the long-term clinical effects of this treatment. The study will be conducted at the Clinique Rhône-Durance. Data on the management of all adult patients with calcified femoropopliteal lesions treated with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 will be collected and recorded for analysis.

Official Title
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3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: atherectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: treated for femoropopliteal lesions with Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between 1 December 2016 and 31 December 2020. Informed and not opposed to the use of their data in this study. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with calcified femoropopliteal lesions<br>Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 | Device: atherectomy<br>* Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Lesions number and proportion | Number and proportion of lesions with absence of Target Lesion Revascularization at 3-year follow-up after the surgery | 3 years after the procedure | 
| Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Target Lesion Revascularization | Estimation of median time between the procedure and the Target Lesion Revascularization | From the date of the procedure until the date of the Target Lesion Revascularization, assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the 3-year clinical outcome of Jetstream atherectomy combined with Ranger, without reoperation, in patients with calcified femoropopliteal lesions | Clinical outcome at 3 years will be assessed by the number and proportion of patients with a reduction in Rutherford category ≥1, or stable at 1 for patients with Rutherford category =1 at inclusion, compared with the baseline value before surgery and without re-intervention | 3 years following the procedure | 
| Evaluation of the procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions - stenosis | The procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of stenosis of residual diameter <30% | During the procedure | 
| Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - dissection | The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with absence of dissection | During the procedure | 
| Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - ruptured vessels | The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of ruptured vessels | During the procedure | 
| Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - distal embolisation | The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of distal embolisation | During the procedure | 
| Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - arteriovenous fistula | The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of arteriovenous (AV) fistula | During the procedure | 
| Assessing the primary patency of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions | Primary patency assessed by echo-Doppler | At 12 months and 36 months | 
| Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - bailout | Atherectomy procedure described by the number and type of additional stents (bailout) implanted | During the procedure | 
| Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - paclitaxel eluting balloons | Atherectomy procedure described by the number of paclitaxel eluting balloons, Ranger (Drug Coat Balloons, DCB), used | During the procedure | 
| Check that there is no revascularisation of clinical origin after the surgery - Target Lesion Revascularization | The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Lesion Revascularization | At 1, 6, 12 and 24 months post-procedure | 
| Check that there is no revascularisation of clinical origin after the surgery - Target Vessel Revascularization | The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Vessel Revascularization | At 1, 6, 12, 24 and 36 months post-procedure | 
| Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Rutherford category | The 3-year clinical follow-up will be described by the number and proportion of patients with an improvement in the Rutherford category (reduction <1) compared with the reference value before surgery | At 1, 6, 12, 24 and 36 months post-procedure | 
| Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Systolic Pressure Index | The 3-year clinical follow-up will be described by the number and proportion of patients with an improvement in Systolic Pressure Index (SPI) (increase ≥0.10) compared with the baseline value before surgery | At 1, 6, 12, 24 and 36 months post-procedure | 
| Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Deaths | The 3-year clinical follow-up will be described by the number and proportion of total deaths and number and proportion of cardiovascular deaths | 3 years following the procedure | 
| Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Amputations | The 3-year clinical follow-up will be described by the number and proportion of patients with major amputations | At 1, 6, 12, 24 and 36 months post-procedure | 
| Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - MACE | The 3-year clinical follow-up will be described by the number and proportion of patients with a major cardiovascular event (MACE) | At 1, 6, 12, 24 and 36 months post-procedure | 
| Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Repeat surgery | The 3-year clinical follow-up will be described by the number and proportion of patients who had a repeat surgery and the total number of repeat surgeries (by cutaneous or bypass route) | 3 years following the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoropopliteal Lesions