CompletedNot Applicable

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

France50 participantsStarted 2023-11-03

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Freedom From Target Lesion Revascularization (TLR)

Timeframe: 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

Timeframe: 3 years after the procedure

Trial details

NCT IDNCT06173960

SponsorAssociation de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-03

Results submitted2025-12-22

View on ClinicalTrials.gov More Peripheral Artery Disease trials