Trial Outcomes & Findings for Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (NCT NCT01883999)

NCT ID: NCT01883999

Last Updated: 2021-11-02

Results Overview

Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: 30 days post-treatment
• Results posted on: 2021-11-02

Participant Flow

Participant milestones

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis
Overall Study STARTED	64
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Baseline characteristics by cohort

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis n=64 Participants GORE® EXCLUDER® Iliac Branch Endoprosthesis
Age, Continuous	69.6 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-treatment

Population: Subjects initiating IBE procedure and meeting inclusion/exclusion criteria

Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.

Outcome measures

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis n=62 Participants GORE® EXCLUDER® Iliac Branch Endoprosthesis
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair	62 participants

PRIMARY outcome

Timeframe: Through 6 month follow-up visit

Population: Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria

Freedom from all of the following:

• Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).
• Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory
• Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.

Outcome measures

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis n=61 Participants GORE® EXCLUDER® Iliac Branch Endoprosthesis
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC	58 participants

SECONDARY outcome

Timeframe: Through 6 month follow-up visit

Population: Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria

Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).

Outcome measures

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis n=61 Participants GORE® EXCLUDER® Iliac Branch Endoprosthesis
Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)	61 participants

Adverse Events

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Serious events: 25 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis n=63 participants at risk GORE® EXCLUDER® Iliac Branch Endoprosthesis
Cardiac disorders Arteriosclerosis coronary artery	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Cardiac disorders Bradycardia	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Cardiac disorders Cardiac failure congestive	3.2% 2/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Cardiac disorders Myocardial infarction	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Cardiac disorders Tachycardia	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Cardiac disorders Ventricular fibrillation	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Gastrointestinal disorders Diverticular perforation	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
General disorders Stent-graft endoleak	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
General disorders Thrombosis in device	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Immune system disorders Contrast media allergy	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Infections and infestations Incision site infection	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Infections and infestations Otitis media	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Infections and infestations Pneumonia	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Infections and infestations Urinary tract infection	4.8% 3/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Injury, poisoning and procedural complications Hip fracture	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Injury, poisoning and procedural complications Urinary retention postoperative	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Musculoskeletal and connective tissue disorders Osteoarthritis	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Nervous system disorders Cerebrovascular accident	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Nervous system disorders Syncope	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Renal and urinary disorders Urinary retention	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Respiratory, thoracic and mediastinal disorders Hypoxia	3.2% 2/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Vascular disorders Aortic dissection	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Vascular disorders Haematoma	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Vascular disorders Hypotension	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Vascular disorders Peripheral artery aneurysm	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Vascular disorders Peripheral artery dissection	1.6% 1/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)

Other adverse events

Measure	GORE® EXCLUDER® Iliac Branch Endoprosthesis n=63 participants at risk GORE® EXCLUDER® Iliac Branch Endoprosthesis
General disorders Stent-graft endoleak	42.9% 27/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Infections and infestations Urinary tract infection	6.3% 4/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Injury, poisoning and procedural complications Incision site pain	12.7% 8/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Musculoskeletal and connective tissue disorders Back pain	11.1% 7/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Renal and urinary disorders Urinary retention	7.9% 5/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Vascular disorders Intermittent claudication	9.5% 6/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 4/63 • 6 months or more of follow-up All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)

Additional Information

Abe Letter

W.L. Gore & Associates

Phone: 928-864-3113

Email: aletter@wlgore.com

Results disclosure agreements

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

Restriction type: OTHER