STAPLE-2: The Pivotal Study of the Aptus Endovascular AAA Repair System

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00507559
• Collaborator: (none)
• Enrollment: 155
• Locations: 2
• Arm: 1
• Duration (Months): 80
• Patients Per Site: 77.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysms (AAA)	Device: Aptus Endovascular AAA Repair System	N/A

Detailed Description

The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).

Study Design

• Study Type: Interventional
• Actual Enrollment: 155 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Pivotal Study of the Aptus Endovascular AAA Repair System
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AAA Repair System	Device: Aptus Endovascular AAA Repair System; EVAR (endovascular aneurysm repair)

Outcome Measures

Primary Outcome Measures

1. Effectiveness: Composite Success Rate [12 months]

   Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.

2. Safety: MAE (Major Adverse Event) [30 days]

   Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group

Secondary Outcome Measures

1. Safety: SAE (Serious Adverse Event) [5 years]

   Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure

2. Effectiveness: Surgical Conversion [12 months]

   Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device.

3. Effectiveness: Aneurysm Rupture [12 months]

   Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure

4. Effectiveness: Aneurysm Change [12 months]

   Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure

5. Effectiveness: EndoStaple Stent/Fracture [12 months]

   Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure

6. Effectiveness: Prosthesis Migration [12 months]

   Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure

7. Effectiveness: Type I Endoleak and Type III Endoleak [12 months]

   Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure

8. Effectiveness: Thrombosis [5 years]

   Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infrarenal AAA with a maximum diameter ≥ 4.5 cm.

• Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck.

• Infrarenal AAA with a proximal neck internal diameter between 19-29 mm.

• Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm.

• Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm.

• Bilateral iliac artery distal fixation sites ≥ 10 mm in length.

• Bilateral iliac arteries with an internal diameter between 9 and 20 mm.

• Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.

Exclusion Criteria:

• Myocardial infarction within past 10 weeks.

• Active systemic infection.

• Ruptured or leaking AAA.

• Mycotic or inflammatory AAA.

• Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes).

• Concomitant TAA or thoracoabdominal aortic aneurysms.

• Requires emergent AAA surgery.

• Previous AAA repair.

• Patients with a body habitus that would prevent imaging required by the study.

• Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery.

• Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair.

• Dialysis dependent renal failure or creatinine > 2.5 mg/dL.

• Allergy to or intolerance of radiopaque contrast agents.

• Patients with a known sensitivity or allergy to implant materials.

• Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure.

• Patients with history of bleeding diathesis or hypercoagulable condition.

• Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone.

• Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Vascular Group	Albany	New York	United States	12208
2	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Medtronic Cardiovascular

Investigators

• Principal Investigator: Ronald M Fairman, M.D, University of Pennsylvania
• Principal Investigator: Manish Mehta, M.D, Albany Medical College & Albany Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT00507559
• Other Study ID Numbers: 2007-01
• First Posted: Jul 26, 2007
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

Participant Flow

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Period Title: Overall Study
STARTED	155
COMPLETED	84
NOT COMPLETED	71

Baseline Characteristics

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Overall Participants	155
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73 (8)
Sex: Female, Male (Count of Participants)
Female	10 6.5%
Male	145 93.5%
Region of Enrollment (participants) [Number]
United States	155 100%

Outcome Measures

1. Primary Outcome

Title	Effectiveness: Composite Success Rate
Description	Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	155
Number [participants]	4 2.6%

2. Primary Outcome

Title	Safety: MAE (Major Adverse Event)
Description	Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	155
Number [participants]	3 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AAA Repair System
	Comments	This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Safety: SAE (Serious Adverse Event)
Description	Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	155
Number [participants]	129 83.2%

4. Secondary Outcome

Title	Effectiveness: Surgical Conversion
Description	Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

143 reflects the number of subjects with data for the 12 month visit.

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	143
Number [participants]	1 0.6%

5. Secondary Outcome

Title	Effectiveness: Aneurysm Rupture
Description	Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

143 reflects the number of subjects with data for the 12 month visit.

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	143
Number [participants]	1 0.6%

6. Secondary Outcome

Title	Effectiveness: Aneurysm Change
Description	Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline.

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	132
Number [participants]	2 1.3%

7. Secondary Outcome

Title	Effectiveness: EndoStaple Stent/Fracture
Description	Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Denominator is number of subjects with adequate x-ray imaging available at 12 months

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	119
Number [participants]	0 0%

8. Secondary Outcome

Title	Effectiveness: Prosthesis Migration
Description	Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The denominator is the number of subjects with adequate CT imaging available at 12 months

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	133
Number [participants]	0 0%

9. Secondary Outcome

Title	Effectiveness: Type I Endoleak and Type III Endoleak
Description	Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Denominator is the number of subjects with adequate CT imaging available at 12 months

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	132
Number [participants]	2 1.3%

10. Secondary Outcome

Title	Effectiveness: Thrombosis
Description	Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected

Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
Measure Participants	155
Number [participants]	64 41.3%

Adverse Events

Time Frame	5 years
Arm/Group Title	AAA Repair System
Arm/Group Description	Aptus Endovascular AAA Repair System: EVAR
All Cause Mortality
	AAA Repair System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AAA Repair System
	Affected / at Risk (%)	# Events
Total	129/155 (83.2%)
Blood and lymphatic system disorders
Anaemia	1/155 (0.6%)	1
Cardiac disorders
Acute myocardial infarction	1/155 (0.6%)	1
Angina pectoris	9/155 (5.8%)	10
Angina unstable	1/155 (0.6%)	1
Arrhythmia	8/155 (5.2%)	9
Atrial fibrillation	1/155 (0.6%)	1
Bradycardia	1/155 (0.6%)	1
Cardiac arrest	1/155 (0.6%)	1
Cardiac failure congestive	7/155 (4.5%)	8
Cardio-respiratory arrest	1/155 (0.6%)	1
Coronary artery disease	2/155 (1.3%)	2
Coronary artery stenosis	1/155 (0.6%)	1
Myocardial infarction	9/155 (5.8%)	9
Syncope	1/155 (0.6%)	1
Ear and labyrinth disorders
Vertigo	1/155 (0.6%)	1
Endocrine disorders
Inappropriate antidiuretic hormone secretion	1/155 (0.6%)	1
Gastrointestinal disorders
Abdominal pain	1/155 (0.6%)	1
Aorto-oesophageal fistula	1/155 (0.6%)	1
Colitis ischaemic	1/155 (0.6%)	1
Constipation	1/155 (0.6%)	1
Diarrhoea	1/155 (0.6%)	1
Gastritis	1/155 (0.6%)	1
Gastrointestinal haemorrhage	7/155 (4.5%)	7
Haemorrhoids	1/155 (0.6%)	1
Inguinal hernia	1/155 (0.6%)	1
Intestinal obstruction	1/155 (0.6%)	1
Large intestine polyp	1/155 (0.6%)	1
Peptic ulcer perforation	1/155 (0.6%)	1
Rectal haemorrhage	1/155 (0.6%)	1
Upper gastrointestinal haemorrhage	1/155 (0.6%)	2
General disorders
Asthenia	1/155 (0.6%)	1
Chest pain	1/155 (0.6%)	1
Death	1/155 (0.6%)	1
Device deployment issue	1/155 (0.6%)	1
Device dislocation	3/155 (1.9%)	3
Device malfunction	1/155 (0.6%)	1
Device occlusion	5/155 (3.2%)	6
Hernia	1/155 (0.6%)	1
Hernia obstructive	1/155 (0.6%)	1
Medical device complication	1/155 (0.6%)	1
Pyrexia	1/155 (0.6%)	1
Stent-graft endoleak	12/155 (7.7%)	15
Thrombosis in device	24/155 (15.5%)	36
Unevaluable event	1/155 (0.6%)	1
Hepatobiliary disorders
Cholecystitis acute	1/155 (0.6%)	1
Infections and infestations
Bacteraemia	1/155 (0.6%)	1
Bronchitis	1/155 (0.6%)	1
Cellulitis	1/155 (0.6%)	1
Clostridial infection	1/155 (0.6%)	1
Diverticulitis	2/155 (1.3%)	2
Encephalitis viral	1/155 (0.6%)	1
Groin abscess	1/155 (0.6%)	1
Incision site cellulitis	1/155 (0.6%)	1
Pneumonia	8/155 (5.2%)	8
Urinary tract infection	2/155 (1.3%)	2
Urosepsis	1/155 (0.6%)	1
Wound infection	2/155 (1.3%)	2
Injury, poisoning and procedural complications
Hip fracture	3/155 (1.9%)	3
Multiple fractures	1/155 (0.6%)	1
Post procedural haemorrhage	2/155 (1.3%)	2
Procedural haemorrhage	2/155 (1.3%)	2
Road traffic accident	1/155 (0.6%)	1
Subdural haematoma	1/155 (0.6%)	1
Urinary retention postoperative	1/155 (0.6%)	1
Vascular graft occlusion	3/155 (1.9%)	7
Vascular injury	2/155 (1.3%)	2
Wound dehiscence	1/155 (0.6%)	1
Investigations
Carcinoembryonic antigen increased	1/155 (0.6%)	1
Metabolism and nutrition disorders
Dehydration	1/155 (0.6%)	1
Hyponatraemia	1/155 (0.6%)	1
Hypovolaemia	1/155 (0.6%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/155 (0.6%)	1
Monarthritis	1/155 (0.6%)	1
Osteoarthritis	1/155 (0.6%)	1
Synovial cyst	1/155 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	1/155 (0.6%)	1
Basal cell carcinoma	1/155 (0.6%)	1
Bladder cancer	3/155 (1.9%)	3
Colon adenoma	1/155 (0.6%)	1
Colon cancer	1/155 (0.6%)	1
Kaposi's sarcoma	1/155 (0.6%)	1
Laryngeal cancer	1/155 (0.6%)	1
Lung neoplasm malignant	3/155 (1.9%)	3
Malignant melanoma	1/155 (0.6%)	1
Meningioma benign	1/155 (0.6%)	1
Metastases to central nervous system	1/155 (0.6%)	1
Metastasis	1/155 (0.6%)	1
Non-small cell lung cancer	2/155 (1.3%)	2
Oropharyngeal squamous cell carcinoma	1/155 (0.6%)	1
Pancreatic carcinoma	1/155 (0.6%)	1
Prostate cancer	6/155 (3.9%)	6
Prostate cancer metastatic	1/155 (0.6%)	1
Renal cell carcinoma	1/155 (0.6%)	1
Small intestine carcinoma	1/155 (0.6%)	1
Squamous cell carcinoma	2/155 (1.3%)	2
Transitional cell carcinoma	1/155 (0.6%)	1
Nervous system disorders
Carotid artery stenosis	2/155 (1.3%)	2
Cerebral haemorrhage	2/155 (1.3%)	2
Cerebrovascular accident	4/155 (2.6%)	5
Haemorrhage intracranial	1/155 (0.6%)	1
Hemiparesis	1/155 (0.6%)	1
Hydrocephalus	1/155 (0.6%)	1
Hypoaesthesia	1/155 (0.6%)	1
Multiple sclerosis	1/155 (0.6%)	1
Transient ischaemic attack	4/155 (2.6%)	5
Psychiatric disorders
Confusional state	1/155 (0.6%)	1
Renal and urinary disorders
Haematuria	1/155 (0.6%)	1
Nephrotic syndrome	1/155 (0.6%)	1
Renal failure acute	2/155 (1.3%)	2
Renal tubular necrosis	1/155 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	2/155 (1.3%)	2
Chronic obstructive pulmonary disease	7/155 (4.5%)	18
Hypoxia	1/155 (0.6%)	1
Pleural effusion	1/155 (0.6%)	1
Pneumothorax	1/155 (0.6%)	1
Pulmonary embolism	2/155 (1.3%)	2
Pulmonary mass	1/155 (0.6%)	1
Pulmonary oedema	1/155 (0.6%)	1
Respiratory failure	5/155 (3.2%)	5
Surgical and medical procedures
Aortic aneurysm repair	1/155 (0.6%)	1
Hip arthroplasty	3/155 (1.9%)	3
Intervertebral disc operation	1/155 (0.6%)	1
Intestinal resection	1/155 (0.6%)	1
Large intestine operation	1/155 (0.6%)	1
Vascular disorders
Aneurysm ruptured	1/155 (0.6%)	1
Aortic stenosis	1/155 (0.6%)	1
Arterial stenosis	1/155 (0.6%)	1
Arteriosclerosis	1/155 (0.6%)	1
Deep vein thrombosis	3/155 (1.9%)	3
Embolism	9/155 (5.8%)	11
Embolism venous	1/155 (0.6%)	1
Femoral artery embolism	1/155 (0.6%)	1
Haematoma	4/155 (2.6%)	5
Hypertension	1/155 (0.6%)	1
Hypotension	4/155 (2.6%)	5
Intermittent claudication	6/155 (3.9%)	8
Orthostatic hypotension	1/155 (0.6%)	1
Peripheral arterial occlusive disease	2/155 (1.3%)	2
Peripheral artery aneurysm	1/155 (0.6%)	1
Peripheral artery stenosis	4/155 (2.6%)	6
Peripheral artery thrombosis	2/155 (1.3%)	3
Peripheral ischaemia	21/155 (13.5%)	25
Vascular occlusion	3/155 (1.9%)	4
Vascular stenosis	4/155 (2.6%)	6
Other (Not Including Serious) Adverse Events
	AAA Repair System
	Affected / at Risk (%)	# Events
Total	148/155 (95.5%)
Blood and lymphatic system disorders
Anaemia	11/155 (7.1%)	11
Cardiac disorders
Arrhythmia	9/155 (5.8%)	10
General disorders
Oedema peripheral	11/155 (7.1%)	12
Pyrexia	17/155 (11%)	17
Stent-graft endoleak	51/155 (32.9%)	55
Thrombosis in device	10/155 (6.5%)	15
Infections and infestations
Pneumonia	8/155 (5.2%)	9
Urinary tract infection	9/155 (5.8%)	11
Renal and urinary disorders
Urinary retention	10/155 (6.5%)	10
Vascular disorders
Hypertension	15/155 (9.7%)	16
Intermittent claudication	22/155 (14.2%)	24

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.