Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tack Implant | Experimental | Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tack Endovascular System | Device | Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days | Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days. | 6 months |
| Safety - Number of Participants With MALE Plus POD at 30 Days | Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months | Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick J. Geraghty, MD | Washington University School of Medicine in St. Louis | Principal Investigator |
| George Adams, MD | Rex Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | United States | ||
| Mission Cardiovascular Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19897335 | Background | Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. | |
| 24126108 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tack Endovascular System (4F) | Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Sep 14, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months | Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months. | 6 months |
| Fremont |
| California |
| 94538 |
| United States |
| Denver VA Medical Center | Denver | Colorado | 80220 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Amita Health Cardiovascular Associates | Elk Grove Village | Illinois | 60007 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 48215 | United States |
| Michigan Vascular Center | Flint | Michigan | 48507 | United States |
| St. Louis Heart & Vascular | St Louis | Missouri | 63136 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| New Mexico Heart Institute, PA | Albuquerque | New Mexico | 87102 | United States |
| Novant Health Heart and Vascular Institute | Matthews | North Carolina | 28204 | United States |
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| WakeMed Hospital | Raleigh | North Carolina | 27609 | United States |
| Lindner Research Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals, Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Palmetto Health USC Medical Group | Columbia | South Carolina | 29203 | United States |
| Kore Cardiovascular Research | Jackson | Tennessee | 38305 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| North Dallas Research Associates | McKinney | Texas | 75069 | United States |
| Mission Research Institute | New Braunfels | Texas | 78130 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Cardiovascular Associates of East Texas | Tyler | Texas | 75701 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | United States |
| Division of Angiology, Medical University Graz | Graz | 8036 | Austria |
| St. Anne's University Hospital Brno | Brno | Czechia |
| Karolinen-Hospital | Arnsberg | 59759 | Germany |
| Franziskus-Hospital Berlin-Radiology | Berlin | 10787 | Germany |
| Westküstenklinikum Heide | Heide | 25746 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Evangelisches Krankenhaus Mülheim an der Ruhr | Mülheim | Germany |
| Krankenhaus Buchholz | Nordheide | 21244 | Germany |
| MEDINOS Kliniken des Landkreises Sonneberg GmbH | Sonneberg | 96515 | Germany |
| Heart & Vascular Center - Semmelweis University | Budapest | 1122 | Hungary |
| Bács-Kiskun County Hospital | Kecskemét | Hungary |
| Auckland Hospital | Auckland | 1023 | New Zealand |
| Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12. |
| 35352604 | Derived | Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2023 Jun;30(3):393-400. doi: 10.1177/15266028221083462. Epub 2022 Mar 30. |
| 35156451 | Derived | Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tack Endovascular System (4F) | Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| BMI | BMI is missing for two subjects. | Mean | Standard Deviation | Kg/m^2 |
| ||||||||||||||||
| BMI >= 30 | BMI is missing for two subjects. | Count of Participants | Participants |
| |||||||||||||||||
| ABI in treated limb | The ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery in the arm. | ABI information is missing for some subjects. Values ≥1.3 are censored as non-compressible. | Mean | Standard Deviation | ratio |
| |||||||||||||||
| TBI in treated limb | The ratio of systolic blood pressure measured at the toe to systolic blood pressure measured at the brachial artery. | TBI information is missing for some subjects | Mean | Standard Deviation | ratio |
| |||||||||||||||
| Rutherford Classification | Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Class Clinical Description 0 Asymptomatic -no hemodynamically significant occlusive disease
| Count of Participants | Participants |
| |||||||||||||||||
| Wound Grade | Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe. For the purpose of this study only, an additional Wound grade of modified 2 was added which permits some additional wounds to be included. | Count of Participants | Participants |
| |||||||||||||||||
| Ischemia Grade | Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe. | Ischemia grade missing for some subjects | Count of Participants | Participants |
| ||||||||||||||||
| Foot Infection Grade | Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe. | Count of Participants | 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 | Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days | Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days. | The number of evaluable subjects for the 6 Month Primacy Efficacy Endpoint was 209. | Posted | Count of Participants | Participants | 6 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Safety - Number of Participants With MALE Plus POD at 30 Days | Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days | Four subjects were not evaluable for the 30 Day primary safety endpoint due to missing the 30 day visit and no additional visits occurred beyond day 30. One subject was not evaluable for the 30 Day primary safety endpoint due to an early 30 day visit and no additional visits Day 30. These subjects were therefore not included in the denominator for the primary safety endpoint analysis. | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months | Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency. | Some subjects had Tack implants placed in multiple lesions | Posted | Number | number of lesions | 6 months | number of lesions | number of lesions |
|
| |||||||||||||||||||||||||
| Secondary | Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months | Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months. | The number of evaluable subjects for Target Limb Salvage at 6 Months was 209. | Posted | Count of Participants | Participants | 6 months |
|
|
Summary of adverse events that have been reported through 210 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tack Endovascular System (4F) | Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s). | 63 | 233 | 179 | 233 | 137 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Microcytic anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute on chronic heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Angina at rest | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure aggravated | Cardiac disorders | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Coronary heart disease | Cardiac disorders | Systematic Assessment |
| ||
| Decompensated heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Decompensation cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Heart failure NYHA class III | Cardiac disorders | Systematic Assessment |
| ||
| Heart insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| New onset angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Non ST segment elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Paroxysmal atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Progressive angina | Cardiac disorders | Systematic Assessment |
| ||
| Right coronary artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| ST segment elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Coprostasis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Retroperitoneal hematoma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ventral hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute chest pain | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Delayed healing of wound | General disorders | Systematic Assessment |
| ||
| In-stent peripheral artery restenosis | General disorders | Systematic Assessment |
| ||
| Opiate withdrawal symptoms | General disorders | Systematic Assessment |
| ||
| Puncture site bleeding | General disorders | Systematic Assessment |
| ||
| Sudden cardiac death | General disorders | Systematic Assessment |
| ||
| Unknown cause of death | General disorders | Systematic Assessment |
| ||
| Acute cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Bacteriuria | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis of toe | Infections and infestations | Systematic Assessment |
| ||
| Clostridial gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Erysipelas | Infections and infestations | Systematic Assessment |
| ||
| Gangrene | Infections and infestations | Systematic Assessment |
| ||
| Gangrene peripheral | Infections and infestations | Systematic Assessment |
| ||
| Gangrene toe | Infections and infestations | Systematic Assessment |
| ||
| Infection of amputation stump | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis of the foot | Infections and infestations | Systematic Assessment |
| ||
| Phlegmon | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia, organism unspecified | Infections and infestations | Systematic Assessment |
| ||
| Postoperative infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Spondylodiscitis | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcus aureus bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection, site not specified | Infections and infestations | Systematic Assessment |
| ||
| Wet gangrene | Infections and infestations | Systematic Assessment |
| ||
| Abdominal wall wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chronic subdural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femoral artery pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture femur | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture of neck of femur | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose NOS | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripheral artery restenosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin tear | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic brain injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gout aggravated | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type II diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Coxarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hyperuricemic arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Polyarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Prepatellar bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Basalioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Diffuse large B-cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Liver carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ovarian granulosa cell tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ataxia | Nervous system disorders | Systematic Assessment |
| ||
| Bleeding intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Drop attacks | Nervous system disorders | Systematic Assessment |
| ||
| Focal epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Syncopal attack | Nervous system disorders | Systematic Assessment |
| ||
| TIA | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Hyperactive delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Transient psychosis | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute on chronic renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Metrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic leg ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diabetic foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Digital ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Ulcer foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Venous ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Medical device battery replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| Abdominal aortic aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Acute limb ischemia | Vascular disorders | Systematic Assessment |
| ||
| Anterior tibial artery perforation | Vascular disorders | Systematic Assessment |
| ||
| Arterial occlusion | Vascular disorders | Systematic Assessment |
| ||
| Arterial stenosis | Vascular disorders | Systematic Assessment |
| ||
| Atherosclerosis of arteries of the extremities | Vascular disorders | Systematic Assessment |
| ||
| Claudication | Vascular disorders | Systematic Assessment |
| ||
| Critical limb ischemia | Vascular disorders | Systematic Assessment |
| ||
| Digital necrosis | Vascular disorders | Systematic Assessment |
| ||
| Dry gangrene foot | Vascular disorders | Systematic Assessment |
| ||
| Dry gangrene toe | Vascular disorders | Systematic Assessment |
| ||
| Extremity necrosis | Vascular disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Iliac artery stenosis | Vascular disorders | Systematic Assessment |
| ||
| Internal hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Ischemic limb pain | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease Fontaine stage IV | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease aggravated | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Peripheral vascular disease | Vascular disorders | Systematic Assessment |
| ||
| Peripheral vascular disease | Vascular disorders | Systematic Assessment |
| ||
| Superficial femoral arterial stenosis | Vascular disorders | Systematic Assessment |
| ||
| Superficial femoral artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Uncontrolled hypertension | Vascular disorders | Systematic Assessment |
| ||
| Varicose vein | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Microcytic anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute on chronic heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Angina at rest | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure aggravated | Cardiac disorders | Systematic Assessment |
| ||
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Coronary heart disease | Cardiac disorders | Systematic Assessment |
| ||
| Decompensated heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Decompensation cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Heart failure NYHA class III | Cardiac disorders | Systematic Assessment |
| ||
| Heart insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Ischaemic heart disease | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| New onset angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Non ST segment elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Paroxysmal atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Progressive angina | Cardiac disorders | Systematic Assessment |
| ||
| Right coronary artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| ST segment elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Meniere's disease aggravated | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Coprostasis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Retroperitoneal hematoma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ventral hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute chest pain | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Delayed healing of wound | General disorders | Systematic Assessment |
| ||
| In-stent peripheral artery restenosis | General disorders | Systematic Assessment |
| ||
| Leg edema | General disorders | Systematic Assessment |
| ||
| Opiate withdrawal symptoms | General disorders | Systematic Assessment |
| ||
| Puncture site bleeding | General disorders | Systematic Assessment |
| ||
| Swelling of limb | General disorders | Systematic Assessment |
| ||
| Acute cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Bacteriuria | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis of toe | Infections and infestations | Systematic Assessment |
| ||
| Clostridial gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Erysipelas | Infections and infestations | Systematic Assessment |
| ||
| Gangrene | Infections and infestations | Systematic Assessment |
| ||
| Gangrene peripheral | Infections and infestations | Systematic Assessment |
| ||
| Gangrene toe | Infections and infestations | Systematic Assessment |
| ||
| Infection of amputation stump | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis of the foot | Infections and infestations | Systematic Assessment |
| ||
| Phlegmon | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia, organism unspecified | Infections and infestations | Systematic Assessment |
| ||
| Postoperative infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Spondylodiscitis | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcus aureus bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection, site not specified | Infections and infestations | Systematic Assessment |
| ||
| Vascular access site infection | Infections and infestations | Systematic Assessment |
| ||
| Wet gangrene | Infections and infestations | Systematic Assessment |
| ||
| Abdominal wall wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chronic subdural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femoral artery pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture femur | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture of neck of femur | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose NOS | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripheral artery restenosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin tear | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic brain injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gout aggravated | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type II diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Coxarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hyperuricemic arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain of lower extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Polyarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Prepatellar bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Basalioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Diffuse large B-cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Liver carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ovarian granulosa cell tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ataxia | Nervous system disorders | Systematic Assessment |
| ||
| Bleeding intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Drop attacks | Nervous system disorders | Systematic Assessment |
| ||
| Focal epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Syncopal attack | Nervous system disorders | Systematic Assessment |
| ||
| TIA | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Hyperactive delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Transient psychosis | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute on chronic renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Metrorrhagia | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic leg ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diabetic foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Digital ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Ulcer foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Venous ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Medical device battery replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| Abdominal aortic aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Acute limb ischemia | Vascular disorders | Systematic Assessment |
| ||
| Anterior tibial artery perforation | Vascular disorders | Systematic Assessment |
| ||
| Arterial occlusion | Vascular disorders | Systematic Assessment |
| ||
| Arterial spasm | Vascular disorders | Systematic Assessment |
| ||
| Arterial stenosis | Vascular disorders | Systematic Assessment |
| ||
| Arteriovenous fistula | Vascular disorders | Systematic Assessment |
| ||
| Artery dissection | Vascular disorders | Systematic Assessment |
| ||
| Atherosclerosis of arteries of the extremities | Vascular disorders | Systematic Assessment |
| ||
| Claudication | Vascular disorders | Systematic Assessment |
| ||
| Critical limb ischemia | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis leg | Vascular disorders | Systematic Assessment |
| ||
| Digital necrosis | Vascular disorders | Systematic Assessment |
| ||
| Dry gangrene foot | Vascular disorders | Systematic Assessment |
| ||
| Dry gangrene toe | Vascular disorders | Systematic Assessment |
| ||
| Extremity necrosis | Vascular disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Iliac artery stenosis | Vascular disorders | Systematic Assessment |
| ||
| Internal hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Ischemic limb pain | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease Fontaine stage IV | Surgical and medical procedures | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease aggravated | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Peripheral embolism | Vascular disorders | Systematic Assessment |
| ||
| Peripheral vascular disease | Vascular disorders | Systematic Assessment |
| ||
| Popliteal artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Reperfusion injury | Vascular disorders | Systematic Assessment |
| ||
| Superficial femoral arterial stenosis | Vascular disorders | Systematic Assessment |
| ||
| Superficial femoral artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Tibial artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Tibial artery stenosis | Vascular disorders | Systematic Assessment |
| ||
| Tibial artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Uncontrolled hypertension | Vascular disorders | Systematic Assessment |
| ||
| Varicose vein | Vascular disorders | Systematic Assessment |
|
PI acknowledges that Clinical Trial is part of multi-center clinical study. Publication of multi-center data requires prior review and consent of both Sponsor and all participating sites. PI agrees that the first publication of the results of the Clinical Trial shall be made in conjunction with results from other participating sites. Provided, however, that if no multi-center publication is made within one year from database lock, then PI may publish individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Aguirre | Philips Image Guided Therapy | (612) 297-6655 | nicolas.aguirre@philips.com |
| Sep 1, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D012816 | Signs and Symptoms |
Not provided
Not provided
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
|
| 2 |
|
|
| 3 |
|
|
| 4 |
|
|
| 5 |
|
|
| 6 |
|
|
| 1 |
|
|
| modified 2 |
|
|
| 2 |
|
|
| 3 |
|
|
| 1 |
|
|
| 2 |
|
|
| 3 |
|
|
| 1 |
|
|
| 2 |
|
|
| 3 |
|
|
|
| number of lesions |
|
|
|