Trial Outcomes & Findings for Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm (NCT NCT00739401)

NCT ID: NCT00739401

Last Updated: 2021-12-10

Results Overview

The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Within 30 Days
• Results posted on: 2021-12-10

Participant Flow

Participant milestones

Measure	Suprarenal Proximal Cuff Extension Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Overall Study STARTED	44
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Measure	Suprarenal Proximal Cuff Extension Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Overall Study patients were not due for the 2 year follow-up	34
Overall Study Death	3
Overall Study Withdrawal by Subject	4

Baseline Characteristics

All available data has been reported

Baseline characteristics by cohort

Measure	Suprarenal Proximal Cuff Extension n=44 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Age, Continuous	70 years STANDARD_DEVIATION 10.1 • n=44 Participants
Sex: Female, Male Female	5 Participants n=44 Participants
Sex: Female, Male Male	39 Participants n=44 Participants
Race/Ethnicity, Customized Race · White	37 Participants n=44 Participants
Race/Ethnicity, Customized Race · Non-White	7 Participants n=44 Participants
Body Mass Index (BMI)	28 kg/m^2 STANDARD_DEVIATION 5.5 • n=44 Participants
Ankle-Brachial Index(ABI) Ankle-brachial index (ABI) - left	1.01 ratio STANDARD_DEVIATION 0.20 • n=9 Participants • All available data has been reported
Ankle-Brachial Index(ABI) Ankle-brachial index (ABI) - Right	1.0 ratio STANDARD_DEVIATION 0.17 • n=9 Participants • All available data has been reported

PRIMARY outcome

Timeframe: Within 30 Days

Population: Out of the 44 subjects enrolled 2 subjects withdrew even before reaching the 30day follow-up visit mark. Thus, 42 subjects were analyzed for the primary outcome.

The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=42 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Number of Subjects With Proximal Type I Endoleak	2 Participants

SECONDARY outcome

Timeframe: Within 30 days

Population: All available data has been reported.

All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=44 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Number of Subjects With Major Adverse Events All-Cause Death	0 Participants
Number of Subjects With Major Adverse Events AAA rupture	0 Participants
Number of Subjects With Major Adverse Events Conversion / Explant	0 Participants
Number of Subjects With Major Adverse Events Coronary Intervention	0 Participants
Number of Subjects With Major Adverse Events Myocardial Infarction	0 Participants
Number of Subjects With Major Adverse Events Renal Failure	1 Participants
Number of Subjects With Major Adverse Events Respiratory Failure	1 Participants
Number of Subjects With Major Adverse Events Secondary Procedure	0 Participants
Number of Subjects With Major Adverse Events Stroke	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: All available data has been reported

Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=40 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Number of Participants With Stent Graft Integrity and Performance Stent Graft Migration	0 Participants
Number of Participants With Stent Graft Integrity and Performance Stent Fracture	0 Participants
Number of Participants With Stent Graft Integrity and Performance Stent Graft Obstruction	0 Participants
Number of Participants With Stent Graft Integrity and Performance Loss of Device Integrity	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: All available data at 30 days is reported

Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak.

Endoleak diagnosis results as reported by the Core Lab.

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=40 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Endoleak Type I (Attachment site)	2 Participants
Endoleak Type II (Collateral)	6 Participants
Endoleak Indeterminant	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: All available data for 30 days has been reported

Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=40 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Aneurysm Morphology Changes	54 mm Standard Deviation 8.7

SECONDARY outcome

Timeframe: 30 days

Population: All available 30 day data has been reported.

Renal function as measured by serum creatinine. Laboratory results,

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=37 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Renal Function	1.08 mg/dL Standard Deviation 0.35

SECONDARY outcome

Timeframe: 30 days

Population: All available data for 30 days has been reported

Aneurysm morphology changes (Volume) as reported by CoreLab.

Outcome measures

Measure	Suprarenal Proximal Cuff Extension n=40 Participants Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Aneurysm Morphology Changes	170 cubic cm(cm^3) Standard Deviation 56

Adverse Events

Suprarenal Proximal Cuff Extension

Serious events: 11 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Measure	Suprarenal Proximal Cuff Extension n=44 participants at risk Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Blood and lymphatic system disorders Blood and Lymphatic Disorders	4.5% 2/44 • Number of events 2 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Cardiac disorders Cardiac Disorders	4.5% 2/44 • Number of events 3 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Gastrointestinal disorders Gastrointestinal Disorders	11.4% 5/44 • Number of events 7 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Product Issues Implant-Related Events	6.8% 3/44 • Number of events 4 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal Disorders	4.5% 2/44 • Number of events 2 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Vascular disorders Other- SFA Rupture	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory Disorders	9.1% 4/44 • Number of events 5 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Surgical and medical procedures Supplemental Procedure	6.8% 3/44 • Number of events 3 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Vascular disorders Vascular Disorders	6.8% 3/44 • Number of events 3 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.

Other adverse events

Measure	Suprarenal Proximal Cuff Extension n=44 participants at risk Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Blood and lymphatic system disorders Blood and Lymphatic System Disorder	9.1% 4/44 • Number of events 5 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Cardiac disorders Cardiac Disorders	2.3% 1/44 • Number of events 2 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Endocrine disorders Endocrine disorders	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Gastrointestinal disorders Gastrointestinal disorders	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
General disorders General disorders	13.6% 6/44 • Number of events 9 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Infections and infestations Infections and Infestations	9.1% 4/44 • Number of events 4 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Metabolism and nutrition disorders Metabolism and nutrition disorders	4.5% 2/44 • Number of events 3 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (inc cysts and polyps)	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Product Issues Product issues	9.1% 4/44 • Number of events 4 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Psychiatric disorders Psychiatric disorders	2.3% 1/44 • Number of events 1 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Renal and urinary disorders Renal and urinary disorders	6.8% 3/44 • Number of events 4 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	9.1% 4/44 • Number of events 5 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Surgical and medical procedures Surgical and medical procedures	18.2% 8/44 • Number of events 11 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.
Vascular disorders Vascular disorders	13.6% 6/44 • Number of events 10 • 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years Specific Adverse Event terms are not collected. Events have been reported using a custom coding with organ system class. This applies to both SAEs and Non SAEs.

Additional Information

Elisa Hebb, VP Clinical Affairs

Endologix

Phone: 949-598-4628

Email: ehebb@endologix.com

Results disclosure agreements

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