Clinical trial NCT06173960: 3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
Official title: 3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Femoropopliteal Lesions
Lead sponsor: Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients treated for femoropopliteal lesions (de novo, single or multiple, mono or bilateral) by Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between December 1st, 2016 and December 31st, 2020 at the Rhône-Durance Clinic in Avignon, France, will be included in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Target Lesion Revascularization
timeFrame: From the date of the procedure until the date of the Target Lesion Revascularization, assessed up to 3 years
measure: Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Lesions number and proportion
timeFrame: 3 years after the procedure
Secondary outcomes:
measure: Evaluation of the 3-year clinical outcome of Jetstream atherectomy combined with Ranger, without reoperation, in patients with calcified femoropopliteal lesions
timeFrame: 3 years following the procedure
measure: Evaluation of the procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions - stenosis
timeFrame: During the procedure
measure: Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - dissection
timeFrame: During the procedure
measure: Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - ruptured vessels
timeFrame: During the procedure
measure: Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - distal embolisation
timeFrame: During the procedure
measure: Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - arteriovenous fistula
timeFrame: During the procedure
measure: Assessing the primary patency of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions
timeFrame: At 12 months and 36 months
measure: Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - bailout
timeFrame: During the procedure
measure: Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - paclitaxel eluting balloons
timeFrame: During the procedure
measure: Check that there is no revascularisation of clinical origin after the surgery - Target Lesion Revascularization
timeFrame: At 1, 6, 12 and 24 months post-procedure
measure: Check that there is no revascularisation of clinical origin after the surgery - Target Vessel Revascularization
timeFrame: At 1, 6, 12, 24 and 36 months post-procedure
measure: Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Rutherford category
timeFrame: At 1, 6, 12, 24 and 36 months post-procedure
measure: Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Systolic Pressure Index
timeFrame: At 1, 6, 12, 24 and 36 months post-procedure
measure: Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Deaths
timeFrame: 3 years following the procedure
measure: Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Amputations
timeFrame: At 1, 6, 12, 24 and 36 months post-procedure
measure: Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - MACE
timeFrame: At 1, 6, 12, 24 and 36 months post-procedure
measure: Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Repeat surgery
timeFrame: 3 years following the procedure
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Rhône-Durance
Study officials:
affiliation: Clinique Rhône-Durance
name: Jérôme BRUNET, Dr
role: PRINCIPAL_INVESTIGATOR
References: