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
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.
Study Type
OBSERVATIONAL
Enrollment
50
Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))
Clinique Rhône-Durance
Avignon, France
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
Time frame: From the date of the procedure until the date of the Target Lesion Revascularization, assessed up to 3 years
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
Time frame: 3 years after the procedure
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
Time frame: 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%
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 3 years following the procedure
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