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

Evaluation of the 3-year Clinical Outcome of Jetstream Atherectomy Combined With Ranger, Without Reoperation, in Patients With Calcified Femoropopliteal Lesions

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.

Time frame: 3 years following the procedure

Number of Participants With Acute Procedural Success

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%

Time frame: 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

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."

Time frame: 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

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

Time frame: During the procedure

Number of Lesions With Distal Embolisation

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.

Time frame: During the procedure (approximately 1 hour)

Number of Lesions With 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 percentage of lesions with the presence of arteriovenous (AV) fistula.

Time frame: During the procedure (approximately 1 hour)

Primary Patency

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.

Time frame: At 12 and 36 months

Number of Participants With Bailout Stenting

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.

Time frame: During the procedure

Description of the Atherectomy Procedure in Patients With Calcified Femoropopliteal Lesions - Paclitaxel Eluting Balloons

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.

Time frame: During the procedure

Number of Participants Without Clinically-Driven Target Lesion Revascularization (TLR)

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

Time frame: At 1, 6, 12, and 24, and 36 months post-procedure (Note: While the study followed patients for 36 months, the protocol explicitly listed 1, 6, 12, and 24 months for this specific secondary TLR outcome.)

Number of Participants With Target Vessel Revascularization (TVR)

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

Time frame: At 1, 6, 12, 24, and 36 months post-procedure

Number of Participants With Improvement in Rutherford Category

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

Time frame: At 1, 6, 12, 24, and 36 months post-procedure

Number of Participants With Improvement in Systolic Pressure Index (SPI)

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

Time frame: At 1, 6, 12, 24 and 36 months post-procedure

Number of Participants With All-Cause Mortality

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

Time frame: 3 years following the procedure

Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Deaths (Cardiovascular Death)

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

Time frame: 3 years following the procedure

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

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.

Time frame: At 1, 6, 12, 24 and 36 months post-procedure

Number of Participants With Major Adverse Cardiovascular Events (MACE)

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.

Time frame: At 1, 6, 12, 24 and 36 months post-procedure

Number of Participants With Repeat Surgery

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)

Time frame: 3 years following the procedure