Trial Outcomes & Findings for 3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions (NCT NCT06173960)

Race and Ethnicity were not collected from any participant.

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.

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.

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.

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%

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."

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

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.

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.

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.

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.

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.

The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Lesion Revascularization

The absence of revascularisation after the surgery was verified by the number and proportion of patients with clinically-induced Target Vessel Revascularization

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

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

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

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

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.

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.

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)