NCT06173960

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	atherectomy	Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))

Timeline

• Start date: 2023-11-03
• Primary completion: 2023-11-03
• Completion: 2024-01-29
• First posted: 2023-12-18
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

1 site across 1 country: France