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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with calcified femoropopliteal lesions | Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atherectomy | Device | Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Target Lesion Revascularization (TLR) | 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. | 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 | 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. | 3 years after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients treated for femoropopliteal lesions (de novo, single or multiple, mono or bilateral) by Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between December 1st, 2016 and December 31st, 2020 at the Rhône-Durance Clinic in Avignon, France, will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme BRUNET, Dr | Clinique Rhône-Durance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Rhône-Durance | Avignon | 84000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Calcified Femoropopliteal Lesions | Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 atherectomy: Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB)) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Calcified Femoropopliteal Lesions | Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 atherectomy: Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB)) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Target Lesion Revascularization (TLR) | 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. | The "Number of lesions at risk" drops over time: Baseline: 63 12 Months: 61 24 Months: 58 36 Months: 52 | Posted | Number | 95% Confidence Interval | Percentage of lesions | 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. | Lesions | Lesions |
|
Follow-up period (36 months)
This is a retrospective study. Per protocol (Section V.B.4), general adverse event data were not collected. Only specific safety endpoints (All-Cause Death, Major Amputation, and Major Adverse Cardiovascular Events) were assessed systematically from medical records. Unsolicited or non-cardiovascular adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Calcified Femoropopliteal Lesions | Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 atherectomy: Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB)) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amputation | Surgical and medical procedures | Systematic Assessment | Amputation of limb |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jérôme Brunet | Cardiovascular Department, Rhône Durance Clinic, Avignon, France | +33 4 90 14 81 90 | jeromebrunet@cardiord.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2023 | Dec 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017073 | Atherectomy |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| 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% | 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." | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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) | 3 years following the procedure |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of FP lesions | Number | lesions |
|
| Hypertension | Count of Participants | Participants |
|
|
|
| Primary | Evaluation of the Long-term Clinical Effects (After 3 Years of Follow-up) of Jetstream Atherectomy Combined With Ranger - Lesions Number and Proportion | 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. | Posted | Count of Units | Lesions | 3 years after the procedure | Lesions | Lesions |
|
|
|
| Secondary | 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. | 46 patients alive after 3 years of follow-up | Posted | Number | participants | 3 years following the procedure |
|
|
|
| Secondary | 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% | Posted | Count of Participants | Participants | During the procedure (approximately 1 hour) |
|
|
|
| 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 | 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." | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| 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 | 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 | Posted | Count of Units | Lesions | During the procedure | Lesions | Lesions |
|
|
|
| Secondary | 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. | Posted | Count of Units | Lesions | During the procedure (approximately 1 hour) | Lesions | Lesions |
|
|
|
| Secondary | 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. | Posted | Count of Units | Lesions | During the procedure (approximately 1 hour) | Lesions | Lesions |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 12 and 36 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| Secondary | 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. | Data for this outcome measure were not collected. Although the protocol specified documenting the number of Ranger balloons, this specific variable was inadvertently omitted from the data collection form, and retrospective retrieval was not feasible. | Posted | During the procedure |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 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.) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At 1, 6, 12, 24, and 36 months post-procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At 1, 6, 12, 24, and 36 months post-procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At 1, 6, 12, 24 and 36 months post-procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 3 years following the procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 3 years following the procedure |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 1, 6, 12, 24 and 36 months post-procedure |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 1, 6, 12, 24 and 36 months post-procedure |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 3 years following the procedure |
|
|
|
| 4 |
| 50 |
| 7 |
| 50 |
| 0 |
| 0 |
| Target Vessel Revascularization | Surgical and medical procedures | Systematic Assessment | Vascular operation |
|
| Embolism | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| During follow-up |
|
| Title | Measurements |
|---|---|
|
| At 36 months |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| Missing |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| At 6 months |
|
| At 12 months |
|
| At 24 months |
|
| At 36 months |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| At 6 Months |
|
| At 12 Months |
|
| At 24 Months |
|
| At 36 Months |
|
| Missing |
|
| Bypass Surgery |
|