Trial Outcomes & Findings for Celect Vena Cava Filter Clinical Trial (NCT NCT00470626)

NCT ID: NCT00470626

Last Updated: 2016-01-25

Results Overview

Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 129 participants
• Primary outcome timeframe: up to 12 months
• Results posted on: 2016-01-25

Participant Flow

Participant milestones

Measure	Celect Vena Cava Filter
Overall Study STARTED	129
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Celect Vena Cava Filter
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	7

Baseline Characteristics

Celect Vena Cava Filter Clinical Trial

Baseline characteristics by cohort

Measure	Celect Vena Cava Filter n=129 Participants
Age, Continuous	51 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants
Cancer Cancer	23 participants n=5 Participants
Cancer No Cancer	106 participants n=5 Participants
Coagulation Disorder Coagulation Disorder	4 participants n=5 Participants
Coagulation Disorder No Coagulation Disorder	125 participants n=5 Participants
Congestive Heart Failure (CHF) CHF	1 participants n=5 Participants
Congestive Heart Failure (CHF) No CHF	128 participants n=5 Participants
Coronary Heart Disease (CHD) CHD	1 participants n=5 Participants
Coronary Heart Disease (CHD) No CHD	128 participants n=5 Participants
Current Deep Venous Thrombosis (DVT) Current DVT	72 participants n=5 Participants
Current Deep Venous Thrombosis (DVT) No Current DVT	57 participants n=5 Participants
Current Pulmonary Embolism (PE) Current PE	50 participants n=5 Participants
Current Pulmonary Embolism (PE) No Current PE	79 participants n=5 Participants
Diabetes Diabetes Type I	2 participants n=5 Participants
Diabetes Diabetes Type II	10 participants n=5 Participants
Diabetes No Diabetes	117 participants n=5 Participants
Gastrointestinal (GI) Disease GI Disease	8 participants n=5 Participants
Gastrointestinal (GI) Disease No GI Disease	121 participants n=5 Participants
Hepatic Disease Hepatic Disease	3 participants n=5 Participants
Hepatic Disease No Hepatic Disease	126 participants n=5 Participants
Hypertension Hypertension	0 participants n=5 Participants
Hypertension No Hypertension	129 participants n=5 Participants
Peripheral Vascular Disease (PVD) PVD	7 participants n=5 Participants
Peripheral Vascular Disease (PVD) No PVD	122 participants n=5 Participants
Pulmonary Disease Pulmonary Disease	33 participants n=5 Participants
Pulmonary Disease No Pulmonary Disease	96 participants n=5 Participants
Renal Disease Renal Disease	5 participants n=5 Participants
Renal Disease No Renal Disease	124 participants n=5 Participants
Stroke Stroke	7 participants n=5 Participants
Stroke No Stroke	122 participants n=5 Participants
Trauma Trauma	38 participants n=5 Participants
Trauma No Trauma	91 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.

Outcome measures

Measure	Celect Vena Cava Filter n=129 Participants
Major Adverse Event Hemorrhage, Perforation	0 participants
Major Adverse Event Pulmonary Embolism	1 participants
Major Adverse Event Procedure or Device-Related Death	2 participants
Major Adverse Event Inferior Vena Cava Occlusion	0 participants
Major Adverse Event Significant Migration	0 participants
Major Adverse Event Filter Fracture	0 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: 129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient's medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients.

Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).

Outcome measures

Measure	Celect Vena Cava Filter n=58 Participants
Successful Retrieval	56 successful retrievals

SECONDARY outcome

Timeframe: up to 12 months

Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made.

A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made.

Outcome measures

Measure	Celect Vena Cava Filter n=58 Participants
Mean Time to Retrieval Attempt	186 days Standard Deviation 124

Adverse Events

Celect Vena Cava Filter

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Celect Vena Cava Filter n=129 participants at risk
Injury, poisoning and procedural complications Hemorrhage, Perforation	0.00% 0/129
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.78% 1/129
Injury, poisoning and procedural complications Procedure or Device Related Death	1.6% 2/129

Other adverse events

Adverse event data not reported

Additional Information

Scott Snyder

Cook

Phone: 765-463-7537

Email: ssnyder@medinst.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60