N/A
Completed N=50
3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
Source: ClinicalTrials.gov NCT06173960 ↗Enrolled (actual)
50
Serious AEs
14.0%
Results posted
Mar 2026
Primary outcomePrimary: Freedom From Target Lesion Revascularization (TLR) — 100.0; 100.0; 98.4; 95.1 Percentage of lesions
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Target Lesion Revascularization (TLR) |
100.0; 100.0; 98.4; 95.1; 91.6 | — |
| PRIMARY Evaluation of the Long-term Clinical Effects (After 3 Years of Follow-up) of Jetstream Atherectomy Combined With Ranger - Lesions Number and Proportion |
57; 2; 4; 58; 5; 0 | — |
| SECONDARY Evaluation of the 3-year Clinical Outcome of Jetstream Atherectomy Combined With Ranger, Without Reoperation, in Patients With Calcified Femoropopliteal Lesions |
46; 45; 1 | — |
| SECONDARY Number of Participants With Acute Procedural Success |
50 | — |
| SECONDARY 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 |
46 | — |
| SECONDARY 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 |
58 | — |
| SECONDARY Number of Lesions With Distal Embolisation |
1; 62 | — |
| SECONDARY Number of Lesions With Arteriovenous (AV) Fistula |
0; 63 | — |
| SECONDARY Primary Patency |
22; 2; 26; 35; 1; 14 | — |
| SECONDARY Number of Participants With Bailout Stenting |
4; 46 | — |
| SECONDARY Description of the Atherectomy Procedure in Patients With Calcified Femoropopliteal Lesions - Paclitaxel Eluting Balloons |
— | — |
| SECONDARY Number of Participants Without Clinically-Driven Target Lesion Revascularization (TLR) |
50; 0; 0; 50; 0; 0 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
50; 0; 0; 50; 0; 0 | — |
| SECONDARY Number of Participants With Improvement in Rutherford Category |
46; 3; 1; 0; 50; 0 | — |
| SECONDARY Number of Participants With Improvement in Systolic Pressure Index (SPI) |
34; 15; 1; 10; 14; 26 | — |
| SECONDARY Number of Participants With All-Cause Mortality |
50; 0; 0; 50; 0; 0 | — |
| SECONDARY Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Deaths (Cardiovascular Death) |
50; 0; 0; 50; 0; 0 | — |
| SECONDARY Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Amputations |
0; 50; 0; 0; 50; 0 | — |
| SECONDARY Number of Participants With Major Adverse Cardiovascular Events (MACE) |
50; 0; 0; 50; 0; 0 | — |
| SECONDARY Number of Participants With Repeat Surgery |
6; 2; 42; 0; 1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06173960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.