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| ID | Type | Description | Link |
|---|---|---|---|
| IDE G080143 | Other Identifier | FDA |
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To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete SE Vascular Stent System | Experimental | COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete SE Vascular Stent System | Device | Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD). |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization. | 12 Months |
| Primary Patency Rate | Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS). | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint. | 30 days |
| Major Adverse Event (MAE) Rate |
Not provided
Inclusion Criteria:
Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur;
Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;
Life expectancy >12 months.
Exclusion Criteria:
Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
Any condition that precludes safe access with percutaneous transluminal angioplasty (PTA) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified;
Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion;
Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure);
History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
Known impaired renal function, defined as creatinine >2.5 mg/dl;
Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
Known white blood cell (WBC) of <3,000 cells/mm3;
Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.
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| Name | Affiliation | Role |
|---|---|---|
| John Laird, MD | University of California, Davis | Principal Investigator |
| Dierk Scheinert, PD | Park-Krankenhaus Leipzig-Sudost GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital | Fremont | California | 94538 | United States | ||
| N. Florida Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24754279 | Derived | Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1. |
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Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.
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| ID | Title | Description |
|---|---|---|
| FG000 | Complete Self-expanding (SE) Vascular Stent System | Device: Complete Self-expanding (SE) Vascular Stent System > > Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Complete SE Vascular Stent System | Device: Complete SE Vascular Stent System> > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system. |
| 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 | Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization. | Intent-to-Treat Population | Posted | Number | percentage of participants | 12 Months |
|
|
12 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 | 1. Complete SE Vascular Stent System | Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arslan Malik - Senior Clinical Research Manager | Medtronic Aortic and Peripheral Vascular | (707) 541-3256 | arslan.malik@medtronic.com |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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|
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint. |
| 6 Months |
| Device Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device. | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). |
| Lesion Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices. | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). |
| Procedure Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge. | At time of deployment to time of hospital discharge |
| Assisted Primary Patency | Defined as vessel patency resulting from a procedure performed in the treated segment. | 12 months |
| Secondary Patency Rate | Defined as vessel patency resulting from any procedure that restores patency. | 12 Months |
| Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category | Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). | 12 months |
| Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 | Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement. | 12 Months |
| Change in Quality of Life - Decrease in Rutherford Class >= 1 Category | Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). | 30 Days |
| Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up. | 12 Months |
| Clinically-driven Target Lesion Revascularization (TLR) Rate | Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15 | 12 Months |
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint. | 24 Months |
| Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint. | 24 Months |
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint. | 36 Months |
| Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint. | 36 Months |
| Gainesville |
| Florida |
| 32605 |
| United States |
| Munroe Regional Medical Center | Ocala | Florida | 34478 | United States |
| AnMed Health | Anderson | South Carolina | 29621 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Primary Patency Rate | Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS). | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 Months |
|
|
|
| Secondary | Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 6 Months |
|
|
|
| Secondary | Device Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device. | Intention-to-Treat (ITT) | Posted | Number | percentage of lesions treated | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). |
|
|
|
| Secondary | Lesion Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices. | Intention-to-Treat (ITT) | Posted | Number | percentage of lesions treated | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). |
|
|
|
| Secondary | Procedure Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge. | Intention-to-Treat (ITT) | Posted | Number | percentage of lesions treated | At time of deployment to time of hospital discharge |
|
|
|
| Secondary | Assisted Primary Patency | Defined as vessel patency resulting from a procedure performed in the treated segment. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | Secondary Patency Rate | Defined as vessel patency resulting from any procedure that restores patency. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 Months |
|
|
|
| Secondary | Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category | Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 | Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 Months |
|
|
|
| Secondary | Change in Quality of Life - Decrease in Rutherford Class >= 1 Category | Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 30 Days |
|
|
|
| Secondary | Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 Months | Stents implanted with x-ray follow-up | Participants |
|
|
|
| Secondary | Clinically-driven Target Lesion Revascularization (TLR) Rate | Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15 | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 12 Months |
|
|
|
| Secondary | Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint. | Intention-to-Treat | Posted | Number | percentage of participants | 24 Months |
|
|
|
| Secondary | Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint. | Intention-to-Treat (ITT) | Posted | Number | percentage of participants | 24 Months | Stents implanted with x-ray follow-up | Participants |
|
|
|
| Secondary | Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint. | Intention-to-Treat | Posted | Number | percentage of participants | 36 Months |
|
|
|
| Secondary | Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint. | Intention-to-Treat | Posted | Number | percentage of participants | 36 Months | Stents implanted with x-ray follow-up | Participants |
|
|
|
| 117 |
| 196 |
| 50 |
| 196 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrioventricular Block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Angiodysplasia | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mesenteric Vein Thrombosis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter Site Haemorrhage | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gait Disturbance | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vessel Puncture Site Haematoma | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Wound Necrosis | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gallbladder Disorder | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Localised Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Osteomyelitis Acute | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Device Electrical Finding | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| In-Stent Arterial Restenosis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Stent Occlusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spinal Claudication | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hip Arthroplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Revascularisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Tendon Sheath Incision | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Wound Debridement | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Occlusive Disease | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Restenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Stenosis Limb | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Artery Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Femoral Arterial Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Femoral Artery Occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Iliac Artery Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Artery Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Vascular Disorder | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Vascular Pseudoaneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D001157 |
| Arterial Occlusive Diseases |