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

NCT06173960 | Completed Results

• 1 other identifier: FIDJI-2023
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Artery Disease

Keywords

Femoropopliteal Lesions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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

• Number of Participants With Acute Procedural Success

  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

  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

  During the procedure

• Number of Lesions With Distal Embolisation

  During the procedure (approximately 1 hour)

Study Arms (1)

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

Interventions

atherectomy DEVICE

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

Patients with calcified femoropopliteal lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique: lead

Study Sites (1)

Clinique Rhône-Durance

Avignon, 84000, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Limitations and Caveats

* The study's principal limitations include the lack of a control group treated with DCB alone and its retrospective single-centre nature. * The protocol did not include provisions for collecting non-SAEs; therefore, a value of '0' indicates that these events were not assessed, rather than establishing that none occurred. * Serious AE collection was restricted to MACE; "6/50" reflects those with MACE; other potential SAEs outside this definition were not recorded.

Results Point of Contact

• Title: Jérôme Brunet
• Organization: Cardiovascular Department, Rhône Durance Clinic, Avignon, France

jeromebrunet@cardiord.fr

+33 4 90 14 81 90

Study Officials

• Jérôme BRUNET, Dr

  Clinique Rhône-Durance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 18, 2023
• Study Start: November 3, 2023
• Primary Completion: November 3, 2023
• Study Completion: January 29, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)