VALIANT CAPTIVIA Post-market Registry (VCOUS)
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Endovascular
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01181947
First received: August 10, 2010
Last updated: February 21, 2013
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aortic Aneurysm, Thoracic |
Device: TEVAR |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study |
Resource links provided by NLM:
Further study details as provided by Medtronic Endovascular:
Primary Outcome Measures:
- Treatment success [ Time Frame: at 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]
technical success and freedom from
- TAA diameter increase of stented segment (>5mm compared to 1 mo),
- Types I/III endoleak,
- Aneurysm rupture,
- Conversion to open surgery,
- Stent graft occlusion,
- Stent graft migration resulting in SAE or secondary intervention.
Secondary Outcome Measures:
- Technical success [ Time Frame: 0 days (assessed intraoperatively). ] [ Designated as safety issue: No ]Successful delivery and deployment of the stent graft (assessed intraoperatively).
- SADE, SAE or TO [ Time Frame: through 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ](Serious) Adverse Device Effects (SADE) Technical Observations (TO) Serious Adverse Events (SAE)
- ACM and ARM [ Time Frame: at 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
| Enrollment: | 100 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
|
Device: TEVAR
Thoracic endovascular aneurysm repair
Other Name: Valiant Captivia stent graft system
|
Detailed Description:
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
- 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
- There will be no minimum nor maximum number of enrolled subjects per investigation site.
- The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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).
Criteria
Inclusion criteria
- Age ≥ 18 years or minimum age as required by local regulations
- Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System
- Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form')
- Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment
- Willingness and ability to comply with the CIP
Exclusion criteria
- High probability of non-adherence to physician's follow-up requirements
- Participation in concurrent interventional trial which may confound study results
- Prior implantation of a thoracic stent graft
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181947
Locations
| Austria | |
| Medical University of Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Germany | |
| Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie | |
| Frankfurt am Main, Germany, D-60590 | |
| Klinikum der J.W.Goethe-Universitat | |
| Frankfurt am Main, Germany, D-60590 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| St Franziskus Hospital GmbH | |
| Muenster, Germany, 48145 | |
| Krankenhaus Barmherzige Bruder Regensburg | |
| Regensburg, Germany, 93049 | |
| Universitatsklinikum Ulm | |
| Ulm, Germany, D-89075 | |
| Italy | |
| Polyclinic Hospital S.Orsola - Malpighi | |
| Bologna, Italy, 40138 | |
| Netherlands | |
| Catharina Ziekenhuis | |
| Eindhoven, Netherlands, 5623 EJ | |
| St. Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435EM | |
| Spain | |
| Hospital Clinico Universitario de Valladolid | |
| Valladolid, Spain, 47005 | |
| Turkey | |
| Baskent University Ankara Hospital | |
| Ankara, Turkey, 06490 | |
| Ege University Hospital | |
| Izmir, Turkey | |
| Dokuz Eylul University | |
| Izmir, Turkey | |
| United Kingdom | |
| St George`s Hospital | |
| London, United Kingdom, SW17 0QT | |
Sponsors and Collaborators
Medtronic Endovascular
Investigators
| Principal Investigator: | Giovanni Torsello, Prof. | St Franziskus Hospital GmbH |
| Principal Investigator: | Rosella Fattori, Prof. | Policlinico S.Orsola Malpighi |
| Principal Investigator: | Carlos Vaquero Puerta, Dr. | Hospital Clinico Universitario de Valladolid |
| Principal Investigator: | Matthew Thompson, Prof. | St. George's Hospital |
| Principal Investigator: | Werner Jaschke, Prof. | Medical University of Innsbruck |
| Principal Investigator: | Yigit Goktay, Prof. | Dokuz Eylül 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: | 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 Ziekenhuis |
| Principal Investigator: | Mustafa Parildar, Prof. | Ege University Hospital |
| Principal Investigator: | Fatih Boyvat, Prof. | Baskent University Ankara Hospital |
More Information
No publications provided by Medtronic Endovascular
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Endovascular |
| ClinicalTrials.gov Identifier: | NCT01181947 History of Changes |
| Other Study ID Numbers: | MDTEV20112009 |
| Study First Received: | August 10, 2010 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Austrian: Ethics Commision Germany: Ethics Commission Italy: Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Spain: Ethics Committee |
Keywords provided by Medtronic Endovascular:
|
Stent graft thoracic aorta dissection aneurysm |
TEVAR VALIANT CAPTIVIA endovascular |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013