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This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Device | Participants receiving the GORE® VIABAHN® Endoprosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Assisted Patency | Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point. | 12 and 24 months |
| Freedom From Target Lesion Revascularization | Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point. | 1, 12 and 24 months |
| Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | The number and proportion of the subjects for whom the occurrence of serious adverse events were reported. | Procedure day, 1, 12, 24, 36, 48 and 60 months |
| Number of Participants With a Stent Fracture | The number and proportion of stent fracture as assessed by Core lab | Month 12, 24, 36, 48 and 60 |
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Inclusion Criteria:
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Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Rousai | Amagasaki | Hyōgo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38544413 | Derived | Iida O, Ohki T, Soga Y, Suematsu N, Nakama T, Yamaoka T, Tobita K, Ichihashi S. Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study. Vasc Med. 2024 Aug;29(4):416-423. doi: 10.1177/1358863X241233528. Epub 2024 Mar 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® VIABAHN® Endoprosthesis | Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® VIABAHN® Endoprosthesis | Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the 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 | 3 participants are missing age |
| 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 | Primary Assisted Patency | Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point. | Participant limbs treated | Posted | Number | 95% Confidence Interval | probability | 12 and 24 months | limbs | limbs |
|
|
60 months (Days 0 through 1855)
The post-market surveillance study was conducted in compliance with GPSP (Good Post-marketing Study Practice). All Serious Adverse Events regardless of their causal relationship with the study device are reported. However, non-serious events that are not related to the study device or procedure are rarely reported. All non-serious events reported were not in sufficient quantity to meet the reporting frequency threshold for Other Adverse Events.
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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 | GORE® VIABAHN® Endoprosthesis | Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | 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 | 314-440-2110 | 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 | Jun 7, 2016 | Oct 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2019 | Sep 7, 2023 | SAP_001.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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| Death |
|
| Amputation that removes study device |
|
| Surgical bypass |
|
| Changing hospital |
|
| Unable to attend hospital |
|
| 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 | Number | participants |
|
| Participants |
|
| limbs |
|
|
| Primary | Freedom From Target Lesion Revascularization | Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point. | Participant limbs treated | Posted | Number | 95% Confidence Interval | probability | 1, 12 and 24 months | limbs | limbs |
|
|
|
| Primary | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | The number and proportion of the subjects for whom the occurrence of serious adverse events were reported. | Participants must have been followed for at least as long as the start day identified for the time period. Participants that discontinued prior to the start day of the time period were not included in the number analyzed. | Posted | Count of Participants | Participants | Procedure day, 1, 12, 24, 36, 48 and 60 months |
|
|
|
| Primary | Number of Participants With a Stent Fracture | The number and proportion of stent fracture as assessed by Core lab | Includes all subjects who had an x-ray to determine device stent fracture status at the reported corresponding follow-up time period. | Posted | Count of Participants | Participants | Month 12, 24, 36, 48 and 60 |
|
|
|
| 85 |
| 321 |
| 188 |
| 321 |
| 0 |
| 321 |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Acute on chronic heart failure | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Atrial fibrillation paroxysmal | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiac failure aggravated | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiac valvulopathy | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Ischaemic heart disease | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Left anterior descending coronary artery stenosis | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Mesenteric arterial occlusion | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Mesenteric artery stenosis | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial stent occlusion | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Found dead (cause undetermined) | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| In-stent arterial restenosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| In-stent arterial stenosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| In-stent coronary artery restenosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Inflammatory reaction | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Stent restenosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Sudden arrhythmic death syndrome | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Vascular stent-graft occlusion | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Vascular stent-graft stenosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Vascular stent-graft thrombosis | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Endocarditis infective | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Panperitonitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Vascular stent graft infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Acute subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial bypass occlusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial bypass stenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Coronary artery reocclusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Femoral artery pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Femoropopliteal artery bypass occlusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Plaque shift | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Popliteal artery pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Superficial femoral arterial restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Trochanteric femoral fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Ankle brachial index decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
|
| Nutritional condition abnormal | Investigations | MedDRA Version 24.1 | Systematic Assessment |
|
| Geromarasmus | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Advanced lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Brain tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Carcinomatous peritonitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Liver tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Lung cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
|
| Bilateral recurrent laryngeal nerve paralysis | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cardioembolic stroke | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Epileptiform fits NOS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Internal carotid artery stenosis | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA Version 24.1 | Systematic Assessment |
|
| Suicide | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Bilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Interstitial pneumonia aggravated | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Digital ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Ischaemic leg ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Lower extremities ulcers of | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
|
| Peripheral artery stent insertion | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
|
| Abdominal aortic aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Arterial stenosis leg | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Claudication | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Critical limb ischaemia | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Dialysis hypotension | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Iliac artery dissection | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Iliac artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Lower limb ischaemia | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Obstructive arteriosclerosis of lower extremities | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Popliteal artery occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Superficial femoral arterial stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Superficial femoral artery occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Thoracic aortic aneurysm | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Tibial artery occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Tibial artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Vascular dissection | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
The PI is required to obtain written permission from the Sponsor prior to publishing trial results.
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Title | Measurements |
|---|---|
|
|
| 3 Months (Days 38 through 121) |
|
|
| 6 Months (Days 122 through 212) |
|
|
| 12 Months (Days 213 through 395) |
|
|
| 24 Months (Days 396 through 760) |
|
|
| 36 Months (Days 761 through 1277) |
|
|
| 48 Months (Days 1278 through 1642) |
|
|
| 60 Months (Days 1643 through 1855) |
|
|
|
| 36 Months |
|
|
| 48 Months |
|
|
| 60 Months |
|
|