Peripheral Artery Disease
Conditions
Keywords
Femoropopliteal Lesions
Brief 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.
Interventions
DEVICEatherectomy
Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))
Sponsors
Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Target Lesion Revascularization (TLR) | 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. | 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. |
| Evaluation of the Long-term Clinical Effects (After 3 Years of Follow-up) of Jetstream Atherectomy Combined With Ranger - Lesions Number and Proportion | 3 years after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the 3-year Clinical Outcome of Jetstream Atherectomy Combined With Ranger, Without Reoperation, in Patients With Calcified Femoropopliteal Lesions | 3 years following the procedure | 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. |
| Number of Participants With Acute Procedural Success | During the procedure (approximately 1 hour) | 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% |
| 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 | During the procedure | 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." |
| 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 | During the procedure | 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 |
| Number of Lesions With Distal Embolisation | During the procedure (approximately 1 hour) | 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. |
| Number of Lesions With Arteriovenous (AV) Fistula | During the procedure (approximately 1 hour) | 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 | At 12 and 36 months | 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. |
| Number of Participants With Bailout Stenting | During the procedure | 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. |
| Description of the Atherectomy Procedure in Patients With Calcified Femoropopliteal Lesions - Paclitaxel Eluting Balloons | During the procedure | 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. |
| Number of Participants Without Clinically-Driven Target Lesion Revascularization (TLR) | 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.) | The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Lesion Revascularization |
| Number of Participants With Target Vessel Revascularization (TVR) | At 1, 6, 12, 24, and 36 months post-procedure | The absence of revascularisation after the surgery was verified by the number and proportion of patients with clinically-induced Target Vessel Revascularization |
| Number of Participants With Improvement in Rutherford Category | At 1, 6, 12, 24, and 36 months post-procedure | 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 |
| Number of Participants With Improvement in Systolic Pressure Index (SPI) | At 1, 6, 12, 24 and 36 months post-procedure | 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 |
| Number of Participants With All-Cause Mortality | 3 years following the procedure | 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 |
| Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Deaths (Cardiovascular Death) | 3 years following the procedure | 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 |
| Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Amputations | At 1, 6, 12, 24 and 36 months post-procedure | 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. |
| Number of Participants With Major Adverse Cardiovascular Events (MACE) | At 1, 6, 12, 24 and 36 months post-procedure | 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. |
| Number of Participants With Repeat Surgery | 3 years following the procedure | 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) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJérôme BRUNET, Dr
Clinique Rhône-Durance
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 72.7 years STANDARD_DEVIATION 9.8 |
| Hypertension | 42 Participants |
| Number of FP lesions | 63 lesions |
| Region of Enrollment France | 50 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 50 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 7 / 50 |
Outcome results
None listed