VALIANT CAPTIVIA Post-market Registry

NCT01181947 | Terminated Results

• 1 other identifier: MDTEV20112009
• Study Type: observational
• Target: 100
• Locations: 7 countries
• Sites: 15

Brief Summary

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.

Conditions

Aortic Aneurysm, Thoracic

Keywords

Stent graft; thoracic aorta; dissection; aneurysm; TEVAR; VALIANT; CAPTIVIA; endovascular

Outcome Measures

Primary Outcomes (2)

• Treatment Success

  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.

  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

Secondary Outcomes (2)

• SAE

  through 12 months

• ACM and ARM

  at 30 days, 12 months, 24 months and 36 months

Study Arms (1)

patients undergoing TEVAR

Those with a thoracic aortic aneurysm/dissection

Device: TEVAR

Interventions

TEVAR DEVICE

Thoracic endovascular aneurysm repair

Also known as: Valiant Captivia stent graft system

patients undergoing TEVAR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (15)

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

Klinikum der J.W.Goethe-Universitat

Frankfurt am Main, D-60590, Germany

Location

Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie

Frankfurt am Main, D-60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

St Franziskus Hospital GmbH

Münster, 48145, Germany

Location

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, 93049, Germany

Location

Universitatsklinikum Ulm

Ulm, D-89075, Germany

Location

Polyclinic Hospital S.Orsola - Malpighi

Bologna, 40138, Italy

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435EM, Netherlands

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Baskent University Ankara Hospital

Ankara, 06490, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Ege University Hospital

Izmir, Turkey (Türkiye)

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22545887 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr. Robin Heijmen
• Organization: St. Antonius Ziekenhuis

r.heijmen@antoniusziekenhuis.nl

0031306092047

Study Officials

• Giovanni Torsello, Prof.

  St Franziskus Hospital GmbH

  PRINCIPAL INVESTIGATOR

• Rosella Fattori, Prof.

  Policlinico S.Orsola Malpighi

  PRINCIPAL INVESTIGATOR

• Carlos Vaquero Puerta, Dr.

  Hospital Clínico 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 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

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 13, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 8, 2023
• Results First Posted: January 26, 2015

Record last verified: 2023-01

Locations

DE (6); IT (1); AU (1); TU (3); GB (1); NL (2); ES (1)