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CIP was amended to include long-term FU but, not all sites accepted it so the nr. of pts participating in the extended FU will be small.
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The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009.
The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections.
The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.
Use of controls
This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.
Sample size
There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.
Number of investigation sites and study duration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients undergoing TEVAR | Those with a thoracic aortic aneurysm/dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEVAR | Device | Thoracic endovascular aneurysm repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success | technical success and freedom from
| at 12 months |
| Technical Success at Time of Initial Implant | Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| SAE | Serious Adverse Events (SAE) | through 12 months |
| ACM and ARM | All-cause (ACM), Aneurysm related (ARM) and dissection related mortality |
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Inclusion criteria
Exclusion criteria
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The Valiant Thoracic Stent Graft with the Captivia Delivery System is indicated for treatment of diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The Valiant Thoracic Stent Graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture and restoration of blood flow through the stent graft lumen. The device is intended for use in subjects who are candidates for conventional surgical repair, and in subjects who are not candidates for conventional surgical repair due to pre-existing risk factors.
Study enrolment is open to subjects who in the opinion of the investigator are candidates for endovascular TAA repair with the Valiant Captivia Thoracic Stent Graft System according to the instructions for use (IFU).
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Torsello, Prof. | St Franziskus Hospital GmbH | Principal Investigator |
| Rosella Fattori, Prof. | Policlinico S.Orsola Malpighi | Principal Investigator |
| Carlos Vaquero Puerta, Dr. | Hospital ClÃnico Universitario de Valladolid | Principal Investigator |
| Matthew Thompson, Prof. | St. George's Hospital | Principal Investigator |
| Werner Jaschke, Prof. | Medical University Innsbruck | Principal Investigator |
| Yigit Goktay, Prof. | Dokuz Eylul University | Principal Investigator |
| Karl Heinz Orend, Prof. | Universitatsklinikum Ulm | Principal Investigator |
| Omke Teebken, Prof. | Hannover Medical School | Principal Investigator |
| Thomas Schmitz-Rixen, Prof. | Klinikum der J.W.Goethe-Universitat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | 6020 | Austria | |||
| Klinikum der J.W.Goethe-Universitat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22545887 | Derived | Heijmen RH, Thompson MM, Fattori R, Goktay Y, Teebken OE, Orend KH. Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. J Endovasc Ther. 2012 Apr;19(2):213-25. doi: 10.1583/11-3652MR.1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Undergoing TEVAR | Those with a thoracic aortic aneurysm/dissection> > TEVAR: Thoracic endovascular aneurysm repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Undergoing TEVAR | Those with a thoracic aortic aneurysm/dissection> > TEVAR: Thoracic endovascular aneurysm repair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Treatment Success | technical success and freedom from
| The number of participants analyzed are different for each endpoint based on number of evaluable subjects at each timepoint per endpoint. | Posted | Count of Participants | Participants | at 12 months |
|
12 months
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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 | 1. VCOUS | Medtronic VCOUS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Social circumstances | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin Heijmen | St. Antonius Ziekenhuis | 0031306092047 | r.heijmen@antoniusziekenhuis.nl |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| at 30 days, 12 months, 24 months and 36 months |
| Markus Steinbauer, Dr. |
| Krankenhaus Barmherzige Bruder Regensburg |
| Principal Investigator |
| Stephan Zangos, Dr. | Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie | Principal Investigator |
| Joep Teijink, Dr. | Catharina Ziekenhuis | Principal Investigator |
| Robin Heijmen, Dr. | St. Antonius Hospital | Principal Investigator |
| Mustafa Parildar, Prof. | Ege University Hospital | Principal Investigator |
| Fatih Boyvat, Prof. | Baskent University Ankara Hospital | Principal Investigator |
| Frankfurt am Main |
| D-60590 |
| Germany |
| Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie | Frankfurt am Main | D-60590 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| St Franziskus Hospital GmbH | Münster | 48145 | Germany |
| Krankenhaus Barmherzige Bruder Regensburg | Regensburg | 93049 | Germany |
| Universitatsklinikum Ulm | Ulm | D-89075 | Germany |
| Polyclinic Hospital S.Orsola - Malpighi | Bologna | 40138 | Italy |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435EM | Netherlands |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47005 | Spain |
| Baskent University Ankara Hospital | Ankara | 06490 | Turkey (Türkiye) |
| Dokuz Eylul University | Izmir | Turkey (Türkiye) |
| Ege University Hospital | Izmir | Turkey (Türkiye) |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Participants |
|
| Age, Continuous | Median | Full Range | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Native aorta diameter | Median | Full Range | mm |
|
| OG002 | 3 - Medtronic VCOUS | Aneurysm Rupture within 12 months |
| OG003 | 4 - Medtronic VCOUS | Stent Graft Occlusion within 12 months |
| OG004 | 5 - Medtronic VCOUS | Conversion to Surgery within 12 months |
| OG005 | 6 - Medtronic VCOUS | Stent Graft Migration > 10 mm resulting in SAE or requiring secondary intervention at 12 months |
|
|
| Primary | Technical Success at Time of Initial Implant | Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system | The primary and secondary endpoints will be reported descriptively. By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses. | Posted | Number | 95% Confidence Interval | participants | intraoperatively |
|
|
|
| Secondary | SAE | Serious Adverse Events (SAE) | The primary and secondary endpoints will be reported descriptively. By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses. | Posted | Number | 95% Confidence Interval | participants | through 12 months |
|
|
|
| Secondary | ACM and ARM | All-cause (ACM), Aneurysm related (ARM) and dissection related mortality | Not Posted | at 30 days, 12 months, 24 months and 36 months | Participants |
| 48 |
| 100 |
| 5 |
| 100 |
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Inflammatory Marker Increased | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stent-Graft Endoleak | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Graft Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vascular Bypass Dysfunction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Compartment Syndrome | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Grand Mal Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intracranial Aneurysm | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vocal Cord Paresis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aneurysm Repair | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aortic Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aortic Rupture | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arteriovenous Fistula | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemothorax | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Artery Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Procedural Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vascular Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vessel Puncture Site Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Medical Center or Investigator may, at his/her discretion, publish and/or present publicly the results of the work of Medical Center and/or Investigator performed under this Agreement. However, should Medical Center or Investigator contemplate publishing and/or presenting publicly such results, the Investigator shall provide copies of any abstracts, papers, or manuscripts to Medtronic for review at least 90 (ninety) days prior to submittal for publication or presentation.
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |