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

Peripheral Artery Disease Clinical Trial

— FIDJI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173960
• Other study ID #: FIDJI-2023
• Status: Completed
• Start date: November 3, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: February 2024
• Source: Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 29, 2024
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• atherectomy
Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))

Locations

Country	Name	City	State
France	Clinique Rhône-Durance	Avignon

Sponsors (1)

Lead Sponsor	Collaborator
Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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