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This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filter | Experimental | All subjects enrolled to the study are in this arm. All subjects receive a filter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bard Recovery G2 Filter System | Device | Retrieval of previously placed RECOVERY G2 IVC filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success (Retrieval) | Technical success for retrieval of the filter such that the entire filter is removed. | 1 month post filter retrieval or through 6 months following implantation |
| Clinical Success (Retrieval) | technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention. | Time of Retrieval or through 6 months of implantation |
| Percentage of Participants With Adverse Events Through 30 Days Post Retrieval | Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure | 30 days post retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Filter Migration > 2cm | Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more. | 30 days post retrieval or 6 months following filter placement |
| Incidence of Filter Fracture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John A Kaufman, MD | OHSU, Portland, Oregon | Principal Investigator |
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Eleven Investigators at 11 sites enrolled a total of 100 study subjects between December 7, 2005 and July 24, 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients Receiving the Filter | All enrolled subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving a Filter | Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical Success (Retrieval) | Technical success for retrieval of the filter such that the entire filter is removed. | 61 of 100 patients enrolled underwent filter retrieval during the study. | Posted | Number | participants | 1 month post filter retrieval or through 6 months following implantation |
|
|
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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 | All Patients Receiving the Filter | All enrolled subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Caval Stenosis | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Mass | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Reviere, Director of Clinical Affairs | C.R. Bard | 480-303-2644 | john.reviere@crbard.com |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)
| at 6 months or at retrieval of the filter |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Indication for Placement | Patients with active thromboembolic disease (the presence of Deep Vein Thrombosis (DVT) or pulmonary embolism (PE) within 3 months of study enrollment). | Number | Number of Participants |
|
|
| Primary | Clinical Success (Retrieval) | technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention. | 61/100 patients experienced filter retrieval during the study | Posted | Number | participants | Time of Retrieval or through 6 months of implantation |
|
|
|
| Primary | Percentage of Participants With Adverse Events Through 30 Days Post Retrieval | Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure | 61 of 100 patients underwent filter retrieval during the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days post retrieval |
|
|
|
| Secondary | Filter Migration > 2cm | Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more. | Migration measurement made for 58 retrieved subjects, 22 non-retrieved subjects reaching the 6 month visit, and 2 non-retrieved subjects with attempted retrievals and imaging. | Posted | Number | Percent Subjects with Filter Migration | 30 days post retrieval or 6 months following filter placement |
|
|
|
| Secondary | Incidence of Filter Fracture | occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components) | adequate imaging was available to assess filter integrity in 83 of the 100 participants. | Posted | Number | number of fractured filters | at 6 months or at retrieval of the filter |
|
|
|
| 6 |
| 100 |
| 70 |
| 100 |
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Discomfort due to device penetration | General disorders | Systematic Assessment |
|
| Inferior Vena Caval Occlusion | Vascular disorders | Systematic Assessment |
|
| Pulomonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute Psychosis | Psychiatric disorders | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Adrenal Hemorrhage | Vascular disorders | Systematic Assessment |
|
| Adverse Drug Reaction | General disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia Postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anticoagulation Drug Level Above Therapeutic | Investigations | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Arterial Hemorrhage | Vascular disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
| Breast Cancer in Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
|
| Catheter Site Hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Chronic Respiratory Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Clavicle Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Clostridium Colitis | Infections and infestations | Systematic Assessment |
|
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Device Migration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Diabetic Gastroparesis | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dislocation of Joint Prosthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Drug Hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Edema Peripheral | General disorders | Systematic Assessment |
|
| Endocarditis Staphylococcal | Infections and infestations | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Fluid Overload | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Frequent Bowel Movements | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal Stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | Systematic Assessment |
|
| Groin Abscess | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | Systematic Assessment |
|
| Heparin Induced Thrombocytopenia | General disorders | Systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Ileus Paralytic | Gastrointestinal disorders | Systematic Assessment |
|
| Incision Site Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Joint Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Large Intestinal Ulcer Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | Systematic Assessment |
|
| Lymphedema | Vascular disorders | Systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Major Depression | Psychiatric disorders | Systematic Assessment |
|
| Metabolic Encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Obsessive Compulsive Disorder | Psychiatric disorders | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Patella Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pelvic Abscess | Infections and infestations | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Pericardial Hemorrhage | Cardiac disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Postmastectomy Lymphedema | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative Infection | Infections and infestations | Systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Renal Cysts | Renal and urinary disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | Systematic Assessment |
|
| Renal Mass | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Restless Leg Syndrome | Nervous system disorders | Systematic Assessment |
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| Retroperitoneal Hematoma | Gastrointestinal disorders | Systematic Assessment |
|
| Scan Adrenal Gland Abnormal | Investigations | Systematic Assessment |
|
| Scrotal Edema | Reproductive system and breast disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Thrombophlebitis Superficial | Vascular disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Vena Cava Thrombosis | Vascular disorders | Systematic Assessment |
|
| Vena Caval Injury | Vascular disorders | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Viral Infection | Infections and infestations | Systematic Assessment |
|
| Vocal Cord Paresis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |