Trial Outcomes & Findings for LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (NCT NCT02059057)
NCT ID: NCT02059057
Last Updated: 2021-07-19
Results Overview
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Change in Baseline to 12 months
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
LVRC System
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Overall Study
STARTED
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102
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Overall Study
COMPLETED
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87
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Overall Study
NOT COMPLETED
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15
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
Baseline characteristics by cohort
| Measure |
LVRC System
n=102 Participants
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Age, Continuous
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64.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
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Sex: Female, Male
Female
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58 Participants
n=5 Participants
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Sex: Female, Male
Male
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44 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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101 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Six Minute Walk Test (6MWT)
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313.6 meters
STANDARD_DEVIATION 82.0 • n=5 Participants
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Forced Expiratory Volume in one second (FEV1)
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0.7 Liters
STANDARD_DEVIATION 0.2 • n=5 Participants
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Residual Volume (RV)
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5.2 Liters
STANDARD_DEVIATION 1.3 • n=5 Participants
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St. George's Respiratory Questionnaire (SGRQ)
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57.9 units of a scale
STANDARD_DEVIATION 15.6 • n=5 Participants
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PRIMARY outcome
Timeframe: Change in Baseline to 12 monthsPopulation: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Outcome measures
| Measure |
LVRC System
n=80 Participants
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Mean Change in Six Minute Walk Test (6MWT)
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-22.9 meters
Standard Deviation 72.6
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SECONDARY outcome
Timeframe: Change in Baseline to 12 monthsPopulation: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Outcome measures
| Measure |
LVRC System
n=83 Participants
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
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2.2 % change
Standard Deviation 21.1
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SECONDARY outcome
Timeframe: Change in Baseline to 12 monthsPopulation: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Outcome measures
| Measure |
LVRC System
n=81 Participants
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Mean Change in Residual Volume (RV)
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-0.3 Liters
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Change in Baseline to 12 monthsPopulation: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD. It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.
Outcome measures
| Measure |
LVRC System
n=83 Participants
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
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-4.8 units on a scale
Standard Deviation 14.8
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Adverse Events
LVRC System
Serious events: 56 serious events
Other events: 97 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
LVRC System
n=101 participants at risk
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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Cardiac disorders
Acute Myocardial Infarction
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Aortic Valve Stenosis
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Atrial flutter
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Cardiac Failure Congestive
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Cor Pulmonale
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Coronary Artery Disease
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Coronary Artery Occlusion
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Cardiac disorders
Supraventricular Tachycardia
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Gastrointestinal disorders
Diabetic Gastroparesis
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Gastrointestinal disorders
Gastritis
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Gastrointestinal disorders
Megacolon
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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General disorders
Medical Device Complication
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3.0%
3/101 • Number of events 3 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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General disorders
Non-Cardiac Chest Pain
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2.0%
2/101 • Number of events 2 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Hepatobiliary disorders
Cholecystitis
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Infections and infestations
Aspergillosis
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Infections and infestations
Gastroenteritis
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Infections and infestations
Infective Exacerbation of COPD
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0.99%
1/101 • Number of events 2 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Infections and infestations
Lower Respiratory Tract Infection
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Infections and infestations
Pneumonia
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16.8%
17/101 • Number of events 20 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
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0.99%
1/101 • Number of events 2 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Musculoskeletal and connective tissue disorders
Back Pain
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Nervous system disorders
Neuropathy Peripheral
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Renal and urinary disorders
Renal Failure Acute
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Renal and urinary disorders
Urinary Retention
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
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22.8%
23/101 • Number of events 29 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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2.0%
2/101 • Number of events 2 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Respiratory, thoracic and mediastinal disorders
Haemoptysis
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5.9%
6/101 • Number of events 6 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
4/101 • Number of events 5 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
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0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
2.0%
2/101 • Number of events 2 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.99%
1/101 • Number of events 1 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Other adverse events
| Measure |
LVRC System
n=101 participants at risk
The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
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|---|---|
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General disorders
Chest Discomfort
|
14.9%
15/101 • Number of events 21 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
General disorders
Chest Pain
|
8.9%
9/101 • Number of events 9 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
General disorders
Medical Device Complication
|
7.9%
8/101 • Number of events 8 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
General disorders
Non-Cardiac Chest Pain
|
10.9%
11/101 • Number of events 14 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Infections and infestations
Pneumonia
|
19.8%
20/101 • Number of events 25 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
6/101 • Number of events 6 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Nervous system disorders
Headache
|
8.9%
9/101 • Number of events 11 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
61.4%
62/101 • Number of events 110 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
16/101 • Number of events 23 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.8%
17/101 • Number of events 21 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
57.4%
58/101 • Number of events 96 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
17.8%
18/101 • Number of events 26 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Infections and infestations
Bronchitis
|
8.9%
9/101 • Number of events 11 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
5/101 • Number of events 5 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.9%
7/101 • Number of events 10 • 12 months
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place