3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
- Conditions
- Peripheral Artery Disease
- Interventions
- Device: atherectomy
- Registration Number
- NCT06173960
- Lead Sponsor
- Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with calcified femoropopliteal lesions atherectomy 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
- Primary Outcome Measures
Name Time Method Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Lesions number and proportion 3 years after the procedure Number and proportion of lesions with absence of Target Lesion Revascularization at 3-year follow-up after the surgery
Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Target Lesion Revascularization From the date of the procedure until the date of the Target Lesion Revascularization, assessed up to 3 years Estimation of median time between the procedure and the Target Lesion Revascularization
- Secondary Outcome Measures
Name Time Method Evaluation of the 3-year clinical outcome of Jetstream atherectomy combined with Ranger, without reoperation, in patients with calcified femoropopliteal lesions 3 years following the procedure 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
Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - distal embolisation During the procedure 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
Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Rutherford category At 1, 6, 12, 24 and 36 months post-procedure 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
Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Amputations At 1, 6, 12, 24 and 36 months post-procedure The 3-year clinical follow-up will be described by the number and proportion of patients with major amputations
Evaluation of the procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions - stenosis During the procedure 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%
Check that there is no revascularisation of clinical origin after the surgery - Target Vessel Revascularization At 1, 6, 12, 24 and 36 months post-procedure The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Vessel Revascularization
Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - dissection During the procedure 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
Check that there is no revascularisation of clinical origin after the surgery - Target Lesion Revascularization At 1, 6, 12 and 24 months post-procedure The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Lesion Revascularization
Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Systolic Pressure Index At 1, 6, 12, 24 and 36 months post-procedure 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
Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - MACE At 1, 6, 12, 24 and 36 months post-procedure The 3-year clinical follow-up will be described by the number and proportion of patients with a major cardiovascular event (MACE)
Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Repeat surgery 3 years following the procedure 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)
Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - ruptured vessels During the procedure 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
Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - bailout During the procedure Atherectomy procedure described by the number and type of additional stents (bailout) implanted
Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - arteriovenous fistula During the procedure 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
Assessing the primary patency of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions At 12 months and 36 months Primary patency assessed by echo-Doppler
Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - paclitaxel eluting balloons During the procedure Atherectomy procedure described by the number of paclitaxel eluting balloons, Ranger (Drug Coat Balloons, DCB), used
Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Deaths 3 years following the procedure The 3-year clinical follow-up will be described by the number and proportion of total deaths and number and proportion of cardiovascular deaths
Trial Locations
- Locations (1)
Clinique Rhône-Durance
🇫🇷Avignon, France