Trial Outcomes & Findings for The SENTRY Clinical Study (NCT NCT01975090)

NCT ID: NCT01975090

Last Updated: 2021-10-27

Results Overview

A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 129 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2021-10-27

Participant Flow

Participant milestones

Measure	SENTRY IVC Filter Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
Overall Study STARTED	129
Overall Study 6-month Follow-up	117
Overall Study COMPLETED	117
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The SENTRY Clinical Study

Baseline characteristics by cohort

Measure	SENTRY IVC Filter Group n=129 Participants Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 13.52 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Region of Enrollment Belgium	4 Participants n=5 Participants
Region of Enrollment United States	115 Participants n=5 Participants
Region of Enrollment Chile	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

A Composite Endpoint including:

Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications

Outcome measures

Measure	SENTRY IVC Filter n=114 Participants The SENTRY IVC Bioconvertible Filter SENTRY IVC Filter: The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.	Filter Migration Core Lab reviewed imaging data at 6 month follow-up	Filter Embolization Core Lab reviewed imaging data at 6 month follow-up	Filter Fracture Core Lab reviewed imaging data at 6 month follow-up	Filter Perforation Core Lab reviewed imaging data at 6 month follow-up	Symptomatic Complications Symptomatic Complications is the composite of Symptomatic Caval Thrombosis and Other Symptomatic Complications Requiring Invasive Intervention and filter-related death at 6 months
Number of Subjects That Reported Clinical Success	111 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 6months

Population: Freedom from IVC Filter Related Complications was assessed by the site and reviewed by an Independent Core Lab. All subjects that had data collected were included in the analysis for population.

IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).

Outcome measures

Measure	SENTRY IVC Filter n=114 Participants The SENTRY IVC Bioconvertible Filter SENTRY IVC Filter: The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.	Filter Migration n=114 Participants Core Lab reviewed imaging data at 6 month follow-up	Filter Embolization n=114 Participants Core Lab reviewed imaging data at 6 month follow-up	Filter Fracture n=114 Participants Core Lab reviewed imaging data at 6 month follow-up	Filter Perforation n=114 Participants Core Lab reviewed imaging data at 6 month follow-up	Symptomatic Complications n=126 Participants Symptomatic Complications is the composite of Symptomatic Caval Thrombosis and Other Symptomatic Complications Requiring Invasive Intervention and filter-related death at 6 months
Number of Participants With IVC Filter Related Complications	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants

Adverse Events

SENTRY IVC Filter

Serious events: 45 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Measure	SENTRY IVC Filter n=129 participants at risk Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
Blood and lymphatic system disorders Blood and lymphatic system disorders	3.9% 5/129 • 6 month adverse events were monitored by Organ Class .
Cardiac disorders Cardiac disorders	7.0% 9/129 • 6 month adverse events were monitored by Organ Class .
Gastrointestinal disorders Gastrointestinal disorders	3.9% 5/129 • 6 month adverse events were monitored by Organ Class .
General disorders General disorders and administration site conditions	2.3% 3/129 • 6 month adverse events were monitored by Organ Class .
Immune system disorders Infections and infestations	14.0% 18/129 • 6 month adverse events were monitored by Organ Class .
Injury, poisoning and procedural complications Injury, poisoning, and procedural complications	3.1% 4/129 • 6 month adverse events were monitored by Organ Class .
Metabolism and nutrition disorders Metabolism and nutrition disorders	3.1% 4/129 • 6 month adverse events were monitored by Organ Class .
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.6% 2/129 • 6 month adverse events were monitored by Organ Class .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified (including cysts and polyps)	1.6% 2/129 • 6 month adverse events were monitored by Organ Class .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders	3.9% 5/129 • 6 month adverse events were monitored by Organ Class .
Psychiatric disorders Psychiatric disorders	0.00% 0/129 • 6 month adverse events were monitored by Organ Class .
Renal and urinary disorders Renal and urinary disorders	3.9% 5/129 • 6 month adverse events were monitored by Organ Class .
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders	7.0% 9/129 • 6 month adverse events were monitored by Organ Class .
Vascular disorders Vascular disorders	2.3% 3/129 • 6 month adverse events were monitored by Organ Class .
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/129 • 6 month adverse events were monitored by Organ Class .
Surgical and medical procedures Surgical and medical procedures	0.00% 0/129 • 6 month adverse events were monitored by Organ Class .
Congenital, familial and genetic disorders Congenital, familial, and genetic disorders	0.00% 0/129 • 6 month adverse events were monitored by Organ Class .

Other adverse events

Measure	SENTRY IVC Filter n=129 participants at risk Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
Blood and lymphatic system disorders Blood and lymphatic system disorders	10.1% 13/129 • 6 month adverse events were monitored by Organ Class .
Cardiac disorders Cardiac disorders	14.7% 19/129 • 6 month adverse events were monitored by Organ Class .
Congenital, familial and genetic disorders Congenital, familial and genetic disorders	0.78% 1/129 • 6 month adverse events were monitored by Organ Class .
Gastrointestinal disorders Gastrointestinal disorders	14.7% 19/129 • 6 month adverse events were monitored by Organ Class .
General disorders General disorders and administration site conditions	10.9% 14/129 • 6 month adverse events were monitored by Organ Class .
Infections and infestations Infections and infestations	34.9% 45/129 • 6 month adverse events were monitored by Organ Class .
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	6.2% 8/129 • 6 month adverse events were monitored by Organ Class .
Investigations Investigations	6.2% 8/129 • 6 month adverse events were monitored by Organ Class .
Metabolism and nutrition disorders Metabolism and nutrition disorders	17.1% 22/129 • 6 month adverse events were monitored by Organ Class .
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	9.3% 12/129 • 6 month adverse events were monitored by Organ Class .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	4.7% 6/129 • 6 month adverse events were monitored by Organ Class .
Nervous system disorders Nervous system disorders	13.2% 17/129 • 6 month adverse events were monitored by Organ Class .
Psychiatric disorders Psychiatric disorders	5.4% 7/129 • 6 month adverse events were monitored by Organ Class .
Renal and urinary disorders Renal and urinary disorders	12.4% 16/129 • 6 month adverse events were monitored by Organ Class .
Reproductive system and breast disorders Reproductive system and breast disorders	0.78% 1/129 • 6 month adverse events were monitored by Organ Class .
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	20.2% 26/129 • 6 month adverse events were monitored by Organ Class .
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	3.9% 5/129 • 6 month adverse events were monitored by Organ Class .
Surgical and medical procedures Surgical and medical procedures	4.7% 6/129 • 6 month adverse events were monitored by Organ Class .
Vascular disorders Vascular disorders	13.2% 17/129 • 6 month adverse events were monitored by Organ Class .

Additional Information

Gordon Crowley

Novate Medical

Phone: +353 91 750 030

Email: gordon.crowley@novate.ie

Results disclosure agreements

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