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Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.
This is an observational, prospective, single-arm, post-market registry designed to collect real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative sites in Europe will participate and up to 125 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one year per institutional standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTAG Device with ACTIVE CONTROL | All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTAG Device with ACTIVE CONTROL | Device | Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Procedural Technical Success | Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion | 24 hours |
| Number of Subjects With Treatment Success at 30 Day Visit | Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Freedom From Major Adverse Events at 30 Days | Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients presenting with an indication for endovascular repair of the thoracic aorta are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Torsello, MD, PhD | St Franziskus Hospital GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Angers | Angers | France | ||||
| CHU Strasbourg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32193990 | Derived | Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CTAG Device With ACTIVE CONTROL | All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2017 | Oct 22, 2020 |
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| Number of Subjects With Freedom From Major Adverse Events at 12 Months |
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss |
| 12 Months |
| Number of Subjects With Treatment Success at 12 Month Visit | Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration | One year |
| Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events | Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis. | Days 30, 365, and 455 |
| Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | One year change from first post-implant CT scan in maximum aortic diameter | One year |
| Change in Maximum False Lumen Diameter Among Dissection | One year change from first post-implant CT scan in maximum false lumen diameter | One year |
| Change in Minimum True Lumen Diameter Among Dissection | One year change from first post-implant CT scan in minimum true lumen diameter | One year |
| Change in Maximum Aortic Diameter Among Dissection | One year change from first post-implant CT scan in maximum aortic diameter | One year |
| Strasbourg |
| France |
| University Hospital Köln | Cologne | Germany |
| University of Heidelberg | Heidelberg | Germany |
| St. Franziskus Hospital GmbH | Münster | Germany |
| University Hospital Regensburg | Regensburg | Germany |
| Hospital Civili Brescia | Brescia | Italy |
| Ospedali dei Colli - Monaldi | Naples | Italy |
| Azienda Ospedaliers San Camilla Forlanni | Roma | Italy |
| University Hospital Amsterdam | Amsterdam | Netherlands |
| St Antonius Hospital | Nieuwegein | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital ClÃnico Santiago de Compostela | Santiago de Compostela | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| Orebro University Hospital | Örebro | Sweden |
| Uppsala University | Uppsala | Sweden |
| Leeds General Infirmary | Leeds | United Kingdom |
| St George's Vascular Institute | London | United Kingdom |
| St Thomas' London / Guy's Hospital | London | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CTAG Device With ACTIVE CONTROL | All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | 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 Subjects With Procedural Technical Success | Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion | Posted | Count of Participants | Participants | 24 hours |
|
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| |||||||||||||||||||||||||||
| Primary | Number of Subjects With Treatment Success at 30 Day Visit | Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration | Includes all subjects with treatment failure within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a treatment failure within 30 days and with less than 15 days of follow-up were not included in the analysis. | Posted | Count of Participants | Participants | One month |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Freedom From Major Adverse Events at 30 Days | Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss | Includes all subjects with a Major Adverse Event within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a Major Adverse Event within 30 days and with less than 15 days of follow-up were not included in the analysis. | Posted | Count of Participants | Participants | 30 Days |
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| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Freedom From Major Adverse Events at 12 Months | Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss | Includes all subjects with a Major Adverse Event within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a Major Adverse Event within 12 months and with less than 275 days of follow-up were not included in the analysis. | Posted | Count of Participants | Participants | 12 Months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Treatment Success at 12 Month Visit | Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration | Includes all subjects with treatment failure within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a treatment failure within 12 months and with less than 275 days of follow-up were not included in the analysis. | Posted | Count of Participants | Participants | One year |
|
| |||||||||||||||||||||||||||
| Secondary | Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events | Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis. | Posted | Number | 95% Confidence Interval | Probability | Days 30, 365, and 455 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | One year change from first post-implant CT scan in maximum aortic diameter | Includes all non-dissection subjects who have both post-procedure and 12-month measurements. | Posted | Count of Participants | Participants | One year |
|
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| Secondary | Change in Maximum False Lumen Diameter Among Dissection | One year change from first post-implant CT scan in maximum false lumen diameter | Includes all dissection subjects who have both post-procedure and 12-month measurements. | Posted | Count of Participants | Participants | One year |
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| Secondary | Change in Minimum True Lumen Diameter Among Dissection | One year change from first post-implant CT scan in minimum true lumen diameter | Includes all dissection subjects who have both post-procedure and 12-month measurements. | Posted | Count of Participants | Participants | One year |
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| Secondary | Change in Maximum Aortic Diameter Among Dissection | One year change from first post-implant CT scan in maximum aortic diameter | Includes all dissection subjects who have both post-procedure and 12-month measurements. | Posted | Count of Participants | Participants | One year |
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455 days
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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 | CTAG Device With ACTIVE CONTROL | All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice. | 10 | 127 | 45 | 127 | 0 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Aorto-oesophageal fistula | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Death | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Stent-graft endoleak | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular stent occlusion | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Infective aneurysm | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular device infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular graft haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pancreatogenous diabetes | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Paraplegia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Spinal cord ischaemia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Diaphragmatic disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Aortic rupture | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Novak | W. L. Gore & Associates | 314-440-2119 | enovak@wlgore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2019 | Oct 22, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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