INSIGHT: European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

• Sponsor: Cordis Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02477111
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 93
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysms	Device: Endovascular abdominal aortic aneurysm repair

Detailed Description

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Major Adverse Events (MAE) Through 30 Days [Within 30-days post-procedure]

   MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)

Secondary Outcome Measures

1. Occurence of Major Adverse Events [Through 5 years post-procedure]

2. Number of Participants With Technical Success at Conclusion of Index Procedure [At the conclusion of the index procedure]

   successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location

3. Absence of Type I or III Endoleak [Within 1 year post-procedure]

   defined as absence of type I or III endoleaks and absence of aneurysm enlargement (growth >5mm compared to the 1-month size measurement) within 1-year post-procedure as assessed by the core lab

4. InCraft® - AAA Stent Graft System [Assessed at 1 year]

   Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System

5. Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure [Assessed within 30-days and 1-year post-procedure]

6. Absence of Aneurysm Sac Rupture [Within 1-year post-procedure]

7. Duration of INCRAFT® Procedure (Minutes) [Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography]

   Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

8. Amount of Time Fluoroscopy is Used During the Procedure [Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography]

9. Amount of Contrast Volume Used During the Procedure [Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or Female age 18 years or older

2. Femoral access vessels should be adequate to fit the selected delivery system

3. Proximal neck length ≥ 10mm

4. Aortic neck diameters ≥ 17mm and ≤ 31mm

5. Aortic neck suitable for suprarenal fixation

6. Infrarenal and suprarenal neck angulation ≤ 60°

7. Iliac fixation length ≥ 15mm

8. Iliac diameters ≥ 7mm and ≤ 22mm

9. Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm

10. Morphology suitable for aneurysm repair

11. Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures

12. Subject is willing to comply with the specified follow-up evaluation schedule

Exclusion Criteria:

1. Subject has one of the following:

2. Aneurysm sac rupture or leaking abdominal aortic aneurysm

3. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm

4. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE)

5. Known contraindication to undergoing angiography or anticoagulation

6. Existing AAA surgical graft and/or a AAA stent-graft system

7. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Münster	Münster		Germany	48149

Sponsors and Collaborators

• Cordis Corporation

Investigators

• Principal Investigator: Giovanni Torsello, MD, PhD, Universitätsklinikum Münster
• Principal Investigator: Jean-Pierre Becquemin, MD, PhD, CHU Henri Mondor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cordis Corporation
• ClinicalTrials.gov Identifier: NCT02477111
• Other Study ID Numbers: P13-4601
• First Posted: Jun 22, 2015
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Cordis Corporation: Endovascular repair
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

Participant Flow

Recruitment Details	Participants were recruited based on physician referral at 25 academic medical centers between 2015 and the last participant was enrolled September 15, 2016
Pre-assignment Detail	Of the 154 screened patients, 150 met inclusion criteria were enrolled in the study and 4 were screen fail.

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Period Title: Overall Study
STARTED	150
COMPLETED	139
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Overall Participants	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.6 (8)
Sex: Female, Male (Count of Participants)
Female	16 10.7%
Male	134 89.3%
Angina (Count of Participants)
Count of Participants [Participants]	14 9.3%
Arrhythmia (Count of Participants)
Count of Participants [Participants]	36 24%
Coronary artery disease (Count of Participants)
Count of Participants [Participants]	44 29.3%
Myocardial infarction (Count of Participants)
Count of Participants [Participants]	27 18%
Percutaneous transluminal coronary angioplasty and/or stent (Count of Participants)
Count of Participants [Participants]	28 18.7%
Coronary artery bypass grafting (Count of Participants)
Count of Participants [Participants]	19 12.7%
Hypertension (Count of Participants)
Count of Participants [Participants]	120 80%
Congestive heart failure (Count of Participants)
Count of Participants [Participants]	11 7.3%
Family history of aneurysm (Count of Participants)
Count of Participants [Participants]	8 5.3%
Transient Ischemic Attack (Count of Participants)
Count of Participants [Participants]	6 4%
Stroke (Count of Participants)
Count of Participants [Participants]	9 6%
Carotid endarterectomy/stent (Count of Participants)
Count of Participants [Participants]	2 1.3%
Peripheral arterial disease (Count of Participants)
Count of Participants [Participants]	21 14%
Diabetes (Count of Participants)
Count of Participants [Participants]	29 19.3%
Hypercholesterolemia (Count of Participants)
Count of Participants [Participants]	68 45.3%
Moderate renal insufficiency (Count of Participants)
Count of Participants [Participants]	18 12%
Erectile disfunction (Count of Participants)
Count of Participants [Participants]	22 14.7%
Chronic obstructive pulmonary disease (COPD) (Count of Participants)
Count of Participants [Participants]	35 23.3%
Other chronic lung disease (Count of Participants)
Count of Participants [Participants]	8 5.3%
Liver disease (Count of Participants)
Count of Participants [Participants]	3 2%
Cancer (Count of Participants)
Count of Participants [Participants]	45 30%
History of Smoking (Count of Participants)
Count of Participants [Participants]	122 81.3%
Allergies (Count of Participants)
Count of Participants [Participants]	33 22%
Other relevant medical history (Count of Participants)
Count of Participants [Participants]	37 24.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Major Adverse Events (MAE) Through 30 Days
Description	MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Time Frame	Within 30-days post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	This is a single arm non-randomized study.
Measure Participants	150
Number (95% Confidence Interval) [participants]	0 0%

2. Secondary Outcome

Title	Occurence of Major Adverse Events
Time Frame	Through 5 years post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Number of Participants With Technical Success at Conclusion of Index Procedure
Description	successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location
Time Frame	At the conclusion of the index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Measure Participants	150
Count of Participants [Participants]	149 99.3%

4. Secondary Outcome

Title	Absence of Type I or III Endoleak
Description	defined as absence of type I or III endoleaks and absence of aneurysm enlargement (growth >5mm compared to the 1-month size measurement) within 1-year post-procedure as assessed by the core lab
Time Frame	Within 1 year post-procedure

Outcome Measure Data

Analysis Population Description

population analyzed only includes those that are eligible

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Measure Participants	115
Number (95% Confidence Interval) [participants]	108 72%

5. Secondary Outcome

Title	InCraft® - AAA Stent Graft System
Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Time Frame	Assessed at 1 year

Outcome Measure Data

Analysis Population Description

population analyzed only includes those that are eligible

Arm/Group Title	Absence of Stent-graft Migration (>10 mm) Assessed at 1-year
Arm/Group Description	Absence of stent-graft migration (>10 mm) assessed at 1-year compared to the 1-month size measurement as confirmed by contrast CT-scan or other imaging.
Measure Participants	122
Number (95% Confidence Interval) [participants]	122 81.3%

6. Secondary Outcome

Title	Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
Time Frame	Assessed within 30-days and 1-year post-procedure

Outcome Measure Data

Analysis Population Description

Core lab reported outcome based on received and readable imaging

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Measure Participants	141
Count of Participants [Participants]	141 94%

7. Secondary Outcome

Title	Absence of Aneurysm Sac Rupture
Time Frame	Within 1-year post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absence of Stent-graft Migration (>10 mm) Assessed at 1-year
Arm/Group Description	Absence of stent-graft migration (>10 mm) assessed at 1-year compared to the 1-month size measurement as confirmed by contrast CT-scan or other imaging.
Measure Participants	138
Count of Participants [Participants]	138 92%

8. Secondary Outcome

Title	Duration of INCRAFT® Procedure (Minutes)
Description	Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Time Frame	Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	This is a single arm non-randomized study.
Measure Participants	150
Mean (95% Confidence Interval) [minutes]	42.3

9. Secondary Outcome

Title	Amount of Time Fluoroscopy is Used During the Procedure
Time Frame	Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	This is a single arm non-randomized study.
Measure Participants	150
Mean (95% Confidence Interval) [minutes]	17.3

10. Secondary Outcome

Title	Amount of Contrast Volume Used During the Procedure
Time Frame	Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	InCraft® - AAA Stent Graft System
Arm/Group Description	This is a single arm non-randomized study.
Measure Participants	150
Mean (95% Confidence Interval) [ml]	99.4

Adverse Events

Time Frame	Adverse events are collected from index procedure until completion of study or early termination
Adverse Event Reporting Description	All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
Arm/Group Title	1 Year
Arm/Group Description	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
All Cause Mortality
	1 Year
	Affected / at Risk (%)	# Events
Total	5/149 (3.4%)
Serious Adverse Events
	1 Year
	Affected / at Risk (%)	# Events
Total	37/149 (24.8%)
Cardiac disorders
Cardiac disorders	6/149 (4%)
Gastrointestinal disorders
Gastrointestinal disorders	3/149 (2%)
General disorders
General disorders and administration site conditions	10/149 (6.7%)
Immune system disorders
Immune system disorders	1/149 (0.7%)
Infections and infestations
Infections and infestations	6/149 (4%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	3/149 (2%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	0/149 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps)	3/149 (2%)
Nervous system disorders
Nervous system disorders	10/149 (6.7%)
Renal and urinary disorders
Renal and urinary disorders	2/149 (1.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	3/149 (2%)
Surgical and medical procedures
Surgical and medical procedures	1/149 (0.7%)
Vascular disorders
Vascular disorders	5/149 (3.4%)
Other (Not Including Serious) Adverse Events
	1 Year
	Affected / at Risk (%)	# Events
Total	19/149 (12.8%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	0/149 (0%)
Cardiac disorders
Cardiac arrhythmias	1/149 (0.7%)
General disorders
General disorders and administration site conditions	9/149 (6%)
Infections and infestations
Infections and infestations	2/149 (1.3%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	0/149 (0%)
Investigations
Investigations	0/149 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	1/149 (0.7%)
Nervous system disorders
Nervous system disorders	2/149 (1.3%)
Product Issues
Product issues	1/149 (0.7%)
Psychiatric disorders
Psychiatric disorders	0/149 (0%)
Renal and urinary disorders
Renal and urinary disorders	1/149 (0.7%)
Reproductive system and breast disorders
Reproductive system and breast disorders	1/149 (0.7%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	0/149 (0%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	0/149 (0%)
Surgical and medical procedures
Surgical and medical procedures	0/149 (0%)
Vascular disorders
Vascular disorders	3/149 (2%)

Limitations/Caveats

Number of participants at risk my vary depending on varying windows used for analysis, imaging availability, visits completed and will therefore not be consistent throughout report.

More Information

Certain Agreements

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

There IS 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.