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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: atherectomy

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Clinique Rhône-Durance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with calcified femoropopliteal lesions; 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; Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimates of the percentage of lesions free from clinically driven Target Lesion Revascularization (TLR) at each specified time point. The analysis was performed on the lesion population.	From the date of the procedure until the date of the Target Lesion Revascularization, assessed at 1, 6, 12, 24, and 36 months post-procedure.
Evaluation of the Long-term Clinical Effects (After 3 Years of Follow-up) of Jetstream Atherectomy Combined With Ranger - Lesions Number and Proportion	This primary endpoint measured the number and proportion of lesions with freedom from clinically-driven Target Lesion Revascularization (TLR) at 3 years of follow-up after the index procedure. This analysis was performed on the lesion population, and the frequency (number and percentage) of lesions achieving freedom from TLR were presented.	3 years after the procedure

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 was assessed by the number and percentage 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 The Rutherford Classification assesses the severity of Peripheral Artery Disease (PAD) on a scale from 0 to 6, where lower scores indicate better clinical status: Category 0: Asymptomatic Category 1: Mild claudication Category 2: Moderate claudication Category 3: Severe claudication Category 4: Ischemic rest pain Category 5: Minor tissue loss Category 6: Major tissue loss Clinical success is defined as an improvement (reduction) of at least one category.	3 years following the procedure
Number of Participants With Acute Procedural Success	The procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions was assessed at the time of the procedure by the number and percentage of patients with the presence of stenosis of residual diameter <30%	During the procedure (approximately 1 hour)
Evaluation of the Success of the Jetstream Atherectomy Device Combined With Ranger in Patients With Calcified Femoropopliteal Lesions With Absence of Dissection, Vessel Rupture, Distal Embolization and Arteriovenous Fistula	To evaluate the procedural success of the Jetstream atherectomy combined with Ranger, this composite outcome measure was assessed at the time of the index procedure. Success was determined by documenting the number and proportion of patients who had an absence of the following acute procedural complications: dissection, vessel rupture, distal embolization, and arteriovenous (AV) fistula."	During the procedure
Evaluation of the Success of the Jetstream Atherectomy Device Combined With Ranger in Patients With Calcified Femoropopliteal Lesions Defined as Absence of Dissection, Ruptured Vessels, Distal Embolization and Arteriovenous Fistula	The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions was assessed at the time of the procedure by the number and proportion of lesions with an absence of dissection, ruptured vessels, distal embolization, and arteriovenous fistula	During the procedure
Number of Lesions With Distal Embolisation	The success of the Jetstream atherectomy device combined with Ranger was assessed at the time of the procedure by the number and percentage of lesions with the presence of distal embolisation.	During the procedure (approximately 1 hour)
Number of Lesions With Arteriovenous (AV) Fistula	The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions was assessed at the time of the procedure by the number and percentage of lesions with the presence of arteriovenous (AV) fistula.	During the procedure (approximately 1 hour)
Primary Patency	Primary patency, defined as the percentage of patients without Target Lesion Revascularization (TLR) minus the patients who relapsed without having undergone a new angioplasty, was assessed by echo-Doppler.	At 12 and 36 months
Number of Participants With Bailout Stenting	To describe the procedural details, the atherectomy procedure was documented by the total number and specific type(s) of any additional (bailout) stents implanted at the time of the intervention.	During the procedure
Description of the Atherectomy Procedure in Patients With Calcified Femoropopliteal Lesions - Paclitaxel Eluting Balloons	To provide a complete description of the atherectomy procedure, this outcome documented the total number of Ranger paclitaxel-eluting balloons (Drug Coated Balloons, DCB) used per patient during the intervention.	During the procedure
Number of Participants Without Clinically-Driven Target Lesion Revascularization (TLR)	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, and 36 months post-procedure (Note: While the study followed patients for 36 months, the protocol explicitly listed 1, 6, 12, and 24 months for this specific secondary TLR outcome.)
Number of Participants With Target Vessel Revascularization (TVR)	The absence of revascularisation after the surgery was verified by the number and proportion of patients with clinically-induced Target Vessel Revascularization	At 1, 6, 12, 24, and 36 months post-procedure
Number of Participants With Improvement in Rutherford Category	The 3-year clinical follow-up was 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
Number of Participants With Improvement in Systolic Pressure Index (SPI)	The 3-year clinical follow-up was 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
Number of Participants With All-Cause Mortality	As part of the 3-year clinical follow-up, patient mortality was assessed. This was described by the number and proportion of total deaths (all-cause mortality) as well as the number and proportion of deaths from cardiovascular causes, documented at 1, 6, 12, 24, and 36 months post-intervention	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 - Deaths (Cardiovascular Death)	As part of the 3-year clinical follow-up, patient mortality was assessed. This was described by the number and proportion of total deaths (cardiovascular death) as well as the number and proportion of deaths from cardiovascular causes, documented at 1, 6, 12, 24, and 36 months post-intervention	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	As part of the 3-year clinical follow-up, this outcome assessed the number and proportion of patients who underwent a major amputation. This event was documented at 1, 6, 12, 24, and 36 months after the intervention.	At 1, 6, 12, 24 and 36 months post-procedure
Number of Participants With Major Adverse Cardiovascular Events (MACE)	As part of the 3-year clinical follow-up, this outcome assessed the number and proportion of patients who experienced a major adverse cardiovascular event (MACE). These events were documented at 1, 6, 12, 24, and 36 months post-intervention.	At 1, 6, 12, 24 and 36 months post-procedure
Number of Participants With Repeat Surgery	The 3-year clinical follow-up was 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

Collaborators and Investigators

• Sponsor: Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
• Investigators: Principal Investigator: Jérôme BRUNET, Dr, Clinique Rhône-Durance

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Femoropopliteal Lesions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Angioplasty; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Atherectomy
• Other Study ID Numbers: FIDJI-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No