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This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Device | Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Primary Patency at 12 Months | Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months. | 12 months |
| Number of Subjects With a Safety-related Event at 12 Months | Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Primary Patency | Primary patency is defined as blood flow without occlusion maintained through the device after implant without an intervention. This outcome is estimated through Kaplan-Meier analysis | 12, 24, and 36 months |
| Number of Subject With a Safety-related Event at 24 and 36 Months |
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Inclusion Criteria:
Inclusion to the study requires the patient:
Exclusion Criteria:
Prior to or at the time of implant the patient is / has:
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Patients with a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or presence of mural thrombus (< 2 cm) in the popliteal artery treated since the date of reimbursement in France.
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| Name | Affiliation | Role |
|---|---|---|
| Nabil Chakfé | Hôpitaux Universitaire de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaire de Strasbourg | Strasbourg | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Viabahn | Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VIABAHN® Endoprosthesis | Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Primary Patency at 12 Months | Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months. | Includes all subjects who lost patency within 12 months and all patent subjects with at least a 12 month visit or later. | Posted | Count of Participants | Participants | 12 months |
|
|
36 months
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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 | VIABAHN® Endoprosthesis | Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Novak | W. L. Gore & Associates | 314-440-2119 | enovak@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2015 | Jun 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2016 | Jul 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000094622 | Popliteal Artery Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months. |
| 24 and 36 months |
| Length of Hospital Stay | The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm | During hospitalization, approximately 1-2 days |
| Length of Procedure | The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm. | During procedure, approximately 120 minutes |
| Probability of Primary Assisted Patency | Primary assisted patency is defined as blood flow maintained through the device after implant regardless of repeat interventions performed (without occlusion). This outcome is estimated through Kaplan-Meier analysis. | 12, 24, and 36 months |
| Probability of Freedom From Limb Loss | Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis. | 12, 24, and 36 months |
| Probability of Freedom From Repeat Intervention | Repeat Intervention is defined as any endovascular or surgical procedure performed to treat a stenosis or occlusion with the study device(s) or within 5 millimeters of the proximal or distal edge of the device(s), treatment of endoleaks or other reasons. This outcome is estimated through Kaplan-Meier analysis. | 12, 24, and 36 months |
| Probability of Secondary Patency | Secondary patency is defined as blood flow through the device regardless of repeat interventions performed (with or without occlusion) and freedom from surgical bypass. This outcome is estimated through Kaplan-Meier analysis. | 12, 24, and 36 months |
| Number of Subjects With Technical Success | Technical success is defined as successful aneurysmal exclusion using the study device at time of the procedure without Type I or III endoleaks that require post-procedure intervention within 30 days. | Post-procedure at day 30 |
| Amputation Above the Metatarsals |
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| 36 months follow-up visit missed |
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| Patient did not come back since 4 months follow-up |
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| Patient did not come back to the vascular department |
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| Patient contacted by phone but never came back for his follow-up visits |
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| Patient refused to come back |
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| Patient was contacted on Sep 2020. He is fine but refused to come back for his 36 months |
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| Patient cancelled the follow-up visit twice time |
|
| 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 | Number | participants |
|
|
|
| Primary | Number of Subjects With a Safety-related Event at 12 Months | Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months | Includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 12 months and all subjects free from those events with at least a 12 month visit or later. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Probability of Primary Patency | Primary patency is defined as blood flow without occlusion maintained through the device after implant without an intervention. This outcome is estimated through Kaplan-Meier analysis | All participants are included in the Kaplan-Meier analysis for each time point. | Posted | Number | 95% Confidence Interval | probability | 12, 24, and 36 months |
|
|
|
| Secondary | Number of Subject With a Safety-related Event at 24 and 36 Months | Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months. | For 24 month outcome, includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 24 months and all subjects free from those events with at least a 24 month visit or later (54 subjects). For 36 month outcome, includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 36 months and all subjects free from those events with at least a 36 month visit or later (48 subjects). | Posted | Count of Participants | Participants | 24 and 36 months |
|
|
|
| Secondary | Length of Hospital Stay | The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm | Posted | Count of Participants | Participants | During hospitalization, approximately 1-2 days |
|
|
|
| Secondary | Length of Procedure | The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm. | Subjects with missing procedure times are not included. | Posted | Mean | Standard Deviation | minutes | During procedure, approximately 120 minutes |
|
|
|
| Secondary | Probability of Primary Assisted Patency | Primary assisted patency is defined as blood flow maintained through the device after implant regardless of repeat interventions performed (without occlusion). This outcome is estimated through Kaplan-Meier analysis. | All participants are included in the Kaplan-Meier analysis for each time point. | Posted | Number | 95% Confidence Interval | probability | 12, 24, and 36 months |
|
|
|
| Secondary | Probability of Freedom From Limb Loss | Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis. | All participants are included in the Kaplan-Meier analysis for each time point. | Posted | Number | 95% Confidence Interval | probability | 12, 24, and 36 months |
|
|
|
| Secondary | Probability of Freedom From Repeat Intervention | Repeat Intervention is defined as any endovascular or surgical procedure performed to treat a stenosis or occlusion with the study device(s) or within 5 millimeters of the proximal or distal edge of the device(s), treatment of endoleaks or other reasons. This outcome is estimated through Kaplan-Meier analysis. | All participants are included in the Kaplan-Meier analysis for each time point. | Posted | Number | 95% Confidence Interval | probability | 12, 24, and 36 months |
|
|
|
| Secondary | Probability of Secondary Patency | Secondary patency is defined as blood flow through the device regardless of repeat interventions performed (with or without occlusion) and freedom from surgical bypass. This outcome is estimated through Kaplan-Meier analysis. | All participants are included in the Kaplan-Meier analysis for each time point. | Posted | Number | 95% Confidence Interval | probability | 12, 24, and 36 months |
|
|
|
| Secondary | Number of Subjects With Technical Success | Technical success is defined as successful aneurysmal exclusion using the study device at time of the procedure without Type I or III endoleaks that require post-procedure intervention within 30 days. | Subjects who are not technical failures must have at least 31 days of follow-up in order to be considered a technical success. | Posted | Count of Participants | Participants | Post-procedure at day 30 |
|
|
|
| 3 |
| 60 |
| 32 |
| 60 |
| 0 |
| 60 |
| Anemia iron deficiency | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Cardiac failure Nitric Oxide Synthases (NOS) | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Coronaropathy | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Death | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Endoleak | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Vascular stent thrombosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Renal cyst infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Sinus infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| False aneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
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| Pancreatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
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| Thrombosis in device | Product Issues | MedDRA Version 24.1 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Ankle ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Aneurysm repair | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
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| Coronary Artery Bypass Graft (CABG) | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
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| Femoral-tibial arterial bypass | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
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| Femoropopliteal artery bypass | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
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| Nephrectomy | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
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| Abdominal aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Abdominal aneurysm, ruptured | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Abdominal aortic aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Aneurysm enlargement | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Claudication | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Femoral artery aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Femoral artery thrombosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Hematoma | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Ischaemic limb pain | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Ischemia | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Ischemia peripheral | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Ischemic limb pain | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Leg ischemia | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral artery aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Popliteal artery aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| 36 months |
|
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| Days in Hospital = 4 or more |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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