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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular abdominal aortic aneurysm repair | Device | Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Events (MAE) Through 30 Days | MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) | Within 30-days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Events Through 5 Years Post-Procedure | MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) | Through 5 years post-procedure |
| Number of Participants With Technical Success at Conclusion of Index Procedure |
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Inclusion Criteria:
Exclusion Criteria:
Subject has one of the following:
Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE)
Known contraindication to undergoing angiography or anticoagulation
Existing AAA surgical graft and/or a AAA stent-graft system
Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
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Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Torsello, MD, PhD | Universitätsklinikum Münster | Principal Investigator |
| Jean-Pierre Becquemin, MD, PhD | CHU Henri Mondor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitaire de Bordeaux | Bordeaux | France | ||||
| Hopital Prive Paul d'Egine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38031973 | Derived | Torsello G, Bertoglio L, Kellersmann R, Wever JJ, van Overhagen H, Stavroulakis K. Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study. J Endovasc Ther. 2025 Jun;32(3):766-773. doi: 10.1177/15266028231214162. Epub 2023 Nov 30. | |
| 34995719 | Derived |
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Of the 154 screened patients, 150 met inclusion criteria were enrolled in the study and 4 were screen fail.
Participants were recruited based on physician referral at 25 academic medical centers between 2015 and the last participant was enrolled September 15, 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | InCraft® - AAA Stent Graft System | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location |
| At the conclusion of the index procedure |
| Absence of Type I or III Endoleak | 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 | Within 1 year post-procedure |
| InCraft® - AAA Stent Graft System | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System | Assessed at 1 year |
| 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 |
| Absence of Aneurysm Sac Rupture | Within 1-year post-procedure |
| 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 |
| Amount of Time Fluoroscopy is Used During the Procedure | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography |
| Amount of Contrast Volume Used During the Procedure | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography |
| Champigny-sur-Marne |
| France |
| Augusta Krankenhaus | Düsseldorf | Germany |
| University Hospital Schleswig - Holstein | Kiel | Germany |
| University Medical Center Leipzig | Leipzig | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| St.-Franziskus-Hospital | Münster | Germany |
| Universitätsklinikum Würzburg | Würzburg | Germany |
| Galway Clinic | Galway | Ireland |
| University Hospital Galway | Galway | Ireland |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy |
| Istituto Scientifico H San Raffaele | Milan | Italy |
| Ospedale S. Maria della Misericordia | Perugia | Italy |
| Azienda Ospedaleria San Camillo Forlanin | Rome | Italy |
| Radboud UMC | Nijmegen | Netherlands |
| Haga ziekenhuis | The Hague | Netherlands |
| Hospital Clinic University of Barcelona | Barcelona | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Spain |
| Complejo Universitario Hospitalario de Ourense | Ourense | Spain |
| Skane University Hospital | Malmö | Sweden |
| Hull Royal Infirmary | Hull | United Kingdom |
| Imperial College Healthcare NHS Trust St Mary's Hospital | London | United Kingdom |
| Kings College Hospital | London | United Kingdom |
| Torsello G, Bertoglio L, Kellersmann R, Wever JJ, van Overhagen H, Stavroulakis K; INSIGHT study collaborators. One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2022 Jun;75(6):1904-1911.e3. doi: 10.1016/j.jvs.2021.12.066. Epub 2022 Jan 5. |
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| ID | Title | Description |
|---|---|---|
| BG000 | InCraft® - AAA Stent Graft System | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Angina | Count of Participants | Participants |
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| Arrhythmia | Count of Participants | Participants |
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| Coronary artery disease | Count of Participants | Participants |
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| Myocardial infarction | Count of Participants | Participants |
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| Percutaneous transluminal coronary angioplasty and/or stent | Count of Participants | Participants |
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| Coronary artery bypass grafting | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Congestive heart failure | Count of Participants | Participants |
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| Family history of aneurysm | Count of Participants | Participants |
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| Transient Ischemic Attack | Count of Participants | Participants |
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| Stroke | Count of Participants | Participants |
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| Carotid endarterectomy/stent | Count of Participants | Participants |
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| Peripheral arterial disease | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Hypercholesterolemia | Count of Participants | Participants |
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| Moderate renal insufficiency | Count of Participants | Participants |
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| Erectile disfunction | Count of Participants | Participants |
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| Chronic obstructive pulmonary disease (COPD) | Count of Participants | Participants |
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| Other chronic lung disease | Count of Participants | Participants |
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| Liver disease | Count of Participants | Participants |
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| Cancer | Count of Participants | Participants |
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| History of Smoking | Count of Participants | Participants |
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| Allergies | Count of Participants | Participants |
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| Other relevant medical history | Other relevant medical history include: Anemia, Aortic Arch Aneurysm, Back Pain, Blindness, Bph, Carotid Occlusion, Depression, Diverticulosis, Dystonia, Gastritis, Gerd, Hernia, Hypogastric Aneurysm, Hypothyroidism, Kidney Stone, Macular Dengeneration, Mononucleosis, Obesity, Pain, Pneumothorax, Posterior L4-L5 Decompression, Prostate Hypertrophy, Renal Artery Stenosis, Renal Insufficiency, Rheumatoid Arthritis, Sleep Apnea, Suspicion Of Intraductal Pancreatic Mucinous Neoplasia, Thrombocytopenia, Varicosis, Wegener's Granulomatosis. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Adverse Events (MAE) Through 30 Days | MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) | Posted | Number | 95% Confidence Interval | participants | Within 30-days post-procedure |
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| Secondary | Number of Participants With Major Adverse Events Through 5 Years Post-Procedure | MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) | Posted | Number | 95% Confidence Interval | participants | Through 5 years post-procedure |
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| Secondary | Number of Participants With Technical Success at Conclusion of Index Procedure | successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location | Posted | Count of Participants | Participants | At the conclusion of the index procedure |
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| Secondary | Absence of Type I or III Endoleak | 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 | population analyzed only includes those that are eligible | Posted | Number | 95% Confidence Interval | participants | Within 1 year post-procedure |
|
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| Secondary | InCraft® - AAA Stent Graft System | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System | population analyzed only includes those that are eligible | Posted | Number | 95% Confidence Interval | participants | Assessed at 1 year |
|
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| Secondary | Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure | Core lab reported outcome based on received and readable imaging | Posted | Count of Participants | Participants | Assessed within 30-days and 1-year post-procedure |
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| Secondary | Absence of Aneurysm Sac Rupture | Posted | Count of Participants | Participants | Within 1-year post-procedure |
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| Secondary | Duration of INCRAFT® Procedure (Minutes) | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | Posted | Mean | 95% Confidence Interval | minutes | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography |
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| Secondary | Amount of Time Fluoroscopy is Used During the Procedure | Posted | Mean | 95% Confidence Interval | minutes | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography |
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| Secondary | Amount of Contrast Volume Used During the Procedure | Posted | Mean | 95% Confidence Interval | ml | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography |
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Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INSIGHT | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System | 28 | 124 | 21 | 104 | 22 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Immune system disorders | Immune system disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac arrhythmias | Cardiac disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Product issues | Product Issues | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Systematic Assessment |
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| Eye disorders | Eye disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lee, Clinical Project Manager | Cordis, A Cardinal Health Company | 669-699-6851 | jennifer.lee02@cordis.com |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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