Trial Outcomes & Findings for Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter. (NCT NCT00556426)
NCT ID: NCT00556426
Last Updated: 2012-06-01
Results Overview
Technical success for retrieval of the filter such that the entire filter is removed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
1 month post filter retrieval or through 6 months following implantation
Results posted on
2012-06-01
Participant Flow
Eleven Investigators at 11 sites enrolled a total of 100 study subjects between December 7, 2005 and July 24, 2006.
Participant milestones
| Measure |
All Patients Receiving the Filter
All enrolled subjects
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
All Patients Receiving the Filter
All enrolled subjects
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter.
Baseline characteristics by cohort
| Measure |
Participants Receiving a Filter
n=100 Participants
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.
|
|---|---|
|
Age Continuous
|
52.1 years
STANDARD_DEVIATION 16.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=93 Participants
|
|
Indication for Placement
active thromboembolic disease
|
43 Number of Participants
n=93 Participants
|
|
Indication for Placement
no active thromboembolic disease
|
57 Number of Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 month post filter retrieval or through 6 months following implantationPopulation: 61 of 100 patients enrolled underwent filter retrieval during the study.
Technical success for retrieval of the filter such that the entire filter is removed.
Outcome measures
| Measure |
All Patients Receiving the Filter
n=61 Participants
All enrolled subjects
|
|---|---|
|
Technical Success (Retrieval)
|
58 participants
|
PRIMARY outcome
Timeframe: Time of Retrieval or through 6 months of implantationPopulation: 61/100 patients experienced filter retrieval during the study
technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.
Outcome measures
| Measure |
All Patients Receiving the Filter
n=61 Participants
All enrolled subjects
|
|---|---|
|
Clinical Success (Retrieval)
|
57 participants
|
PRIMARY outcome
Timeframe: 30 days post retrievalPopulation: 61 of 100 patients underwent filter retrieval during the study.
Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure
Outcome measures
| Measure |
All Patients Receiving the Filter
n=61 Participants
All enrolled subjects
|
|---|---|
|
Percentage of Participants With Adverse Events Through 30 Days Post Retrieval
|
14.8 percentage of participants
Interval 7.1 to 26.6
|
SECONDARY outcome
Timeframe: 30 days post retrieval or 6 months following filter placementPopulation: 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.
Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.
Outcome measures
| Measure |
All Patients Receiving the Filter
n=82 Participants
All enrolled subjects
|
|---|---|
|
Filter Migration > 2cm
|
12.2 Percent Subjects with Filter Migration
|
SECONDARY outcome
Timeframe: at 6 months or at retrieval of the filterPopulation: adequate imaging was available to assess filter integrity in 83 of the 100 participants.
occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)
Outcome measures
| Measure |
All Patients Receiving the Filter
n=83 Participants
All enrolled subjects
|
|---|---|
|
Incidence of Filter Fracture
|
1 number of fractured filters
|
Adverse Events
All Patients Receiving the Filter
Serious events: 6 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients Receiving the Filter
n=100 participants at risk
All enrolled subjects
|
|---|---|
|
Vascular disorders
Caval Stenosis
|
1.0%
1/100 • Number of events 76
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.0%
1/100 • Number of events 76
|
|
General disorders
Discomfort due to device penetration
|
1.0%
1/100 • Number of events 76
|
|
Vascular disorders
Inferior Vena Caval Occlusion
|
1.0%
1/100 • Number of events 76
|
|
Respiratory, thoracic and mediastinal disorders
Pulomonary Embolism
|
2.0%
2/100 • Number of events 76
|
Other adverse events
| Measure |
All Patients Receiving the Filter
n=100 participants at risk
All enrolled subjects
|
|---|---|
|
Gastrointestinal disorders
Abdominal Mass
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.0%
1/100 • Number of events 1
|
|
Psychiatric disorders
Acute Psychosis
|
1.0%
1/100 • Number of events 1
|
|
Renal and urinary disorders
Acute Renal Failure
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Adrenal Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Adverse Drug Reaction
|
1.0%
1/100 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
15.0%
15/100 • Number of events 15
|
|
Injury, poisoning and procedural complications
Anemia Postoperative
|
1.0%
1/100 • Number of events 1
|
|
Investigations
Anticoagulation Drug Level Above Therapeutic
|
1.0%
1/100 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Arterial Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Atrial Flutter
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Bacteremia
|
1.0%
1/100 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.0%
3/100 • Number of events 3
|
|
Vascular disorders
Catheter Site Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Chest Pain
|
2.0%
2/100 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
2.0%
2/100 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/100 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Disease
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Clostridium Colitis
|
3.0%
3/100 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
1.0%
1/100 • Number of events 1
|
|
Psychiatric disorders
Confusional State
|
2.0%
2/100 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Coronary Artery Disease
|
1.0%
1/100 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
2.0%
2/100 • Number of events 2
|
|
Vascular disorders
Deep Vein Thrombosis
|
13.0%
13/100 • Number of events 13
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
3/100 • Number of events 3
|
|
Psychiatric disorders
Depression
|
3.0%
3/100 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Migration
|
10.0%
10/100 • Number of events 10
|
|
Gastrointestinal disorders
Diabetic Gastroparesis
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
3/100 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Dislocation of Joint Prosthesis
|
2.0%
2/100 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
2.0%
2/100 • Number of events 2
|
|
Immune system disorders
Drug Hypersensitivity
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Duodenitis
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
3/100 • Number of events 3
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/100 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Pain
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Edema Peripheral
|
2.0%
2/100 • Number of events 2
|
|
Infections and infestations
Endocarditis Staphylococcal
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
2/100 • Number of events 2
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
2/100 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
3.0%
3/100 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal Stenosis
|
1.0%
1/100 • Number of events 1
|
|
General disorders
General Physical Health Deterioration
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Groin Abscess
|
1.0%
1/100 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Hematoma
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Heparin Induced Thrombocytopenia
|
2.0%
2/100 • Number of events 2
|
|
Gastrointestinal disorders
Hiatus Hernia
|
2.0%
2/100 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
1.0%
1/100 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.0%
1/100 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Ileus Paralytic
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Infection
|
1.0%
1/100 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Dislocation
|
2.0%
2/100 • Number of events 2
|
|
Gastrointestinal disorders
Large Intestinal Ulcer Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
Investigations
Liver Function Test Abnormal
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Lymphedema
|
1.0%
1/100 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.0%
1/100 • Number of events 1
|
|
Psychiatric disorders
Major Depression
|
4.0%
4/100 • Number of events 4
|
|
Nervous system disorders
Metabolic Encephalopathy
|
1.0%
1/100 • Number of events 1
|
|
Renal and urinary disorders
Micturition Urgency
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/100 • Number of events 2
|
|
Psychiatric disorders
Obsessive Compulsive Disorder
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Oral Candidiasis
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Pain
|
4.0%
4/100 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
1/100 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
1/100 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Pelvic Abscess
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Pericardial Effusion
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Pericardial Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.0%
3/100 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
12.0%
12/100 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
2/100 • Number of events 2
|
|
Injury, poisoning and procedural complications
Postmastectomy Lymphedema
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Postoperative Infection
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Postoperative Wound Infection
|
1.0%
1/100 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/100 • Number of events 1
|
|
Psychiatric disorders
Psychotic Disorder
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.0%
3/100 • Number of events 3
|
|
General disorders
Pyrexia
|
3.0%
3/100 • Number of events 3
|
|
Renal and urinary disorders
Pyuria
|
1.0%
1/100 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
4/100 • Number of events 4
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
1.0%
1/100 • Number of events 1
|
|
Renal and urinary disorders
Renal Cysts
|
1.0%
1/100 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
3.0%
3/100 • Number of events 3
|
|
Renal and urinary disorders
Renal Impairment
|
2.0%
2/100 • Number of events 2
|
|
Renal and urinary disorders
Renal Mass
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.0%
3/100 • Number of events 3
|
|
Infections and infestations
Respiratory Tract Infection
|
1.0%
1/100 • Number of events 1
|
|
Nervous system disorders
Restless Leg Syndrome
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal Hematoma
|
1.0%
1/100 • Number of events 1
|
|
Investigations
Scan Adrenal Gland Abnormal
|
1.0%
1/100 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal Edema
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Sepsis
|
3.0%
3/100 • Number of events 3
|
|
Injury, poisoning and procedural complications
Seroma
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Sinus Tachycardia
|
2.0%
2/100 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Staphylococcal Infection
|
4.0%
4/100 • Number of events 4
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis Superficial
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
12.0%
12/100 • Number of events 12
|
|
Vascular disorders
Vena Cava Thrombosis
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Vena Caval Injury
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Ventricular Tachycardia
|
3.0%
3/100 • Number of events 3
|
|
Infections and infestations
Viral Infection
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Paresis
|
1.0%
1/100 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/100 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
1.0%
1/100 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60